FDA 药品与器械查询

实时对接美国 FDA 官方开放数据（openFDA），可查询美国上市药品 NDC 目录、医疗器械管理类别与 21 CFR 法规号、以及已获许可的 510(k) 清单，用于出海美国的准入判断、注册路径选择与同类竞品调研。支持中文关键词自动转英文检索。

数据源：美国 FDA 官方开放数据平台 openFDA，实时查询美国上市药品 NDC 目录、器械分类与 510(k) 许可，用于出海美国的准入与合规自查。

支持中文关键词自动转英文检索；此为美国监管口径，与中国 NMPA 批准情况相互独立。

上市药品（NDC）器械分类 510(k) 许可

检索已获 FDA 上市前通告许可的器械清单，可查看同类产品的申请人、K 号与许可日期，用于竞品与等效器械调研。

已将中文关键词转为英文「glucose meter」检索 FDA 数据库。

共找到 49 条与「glucose meter」匹配的结果

当前展示 49 条FDA 510(k) 许可记录；海关数据库提供全球买卖明细与竞争对手出货记录咨询完整数据 ›

K 号	器械名称	申请人	许可日期	结论	产品代码	审查科室
K132288	CARESENS N VOICE MULTI BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N VOICE MULTI BLOOD GLUCOSE METER	I-Sens, Inc.	2013-11-22	Substantially Equivalent	NBW	Clinical Chemistry
K855178	DIATRON BLOOD GLUCOSE METER	Dextron, Inc.	1986-08-04	Substantially Equivalent	CGA	Clinical Chemistry
K010039	QUICKTEK BLOOD GLUCOSE SYSTEM, QUICKTEK BLOOD GLUCOSE METER, QUICKTEK BLOOD GLUCOSE STRIPS, QUICKTEK CONTROL SOLUTION	Chronimed, Inc.	2001-08-10	Substantially Equivalent	NBW	Clinical Chemistry
K092875	ECHO TD-3227 DUAL BLOOD PRESSURE/BLOOD GLUCOSE METER	Taidoc Technology Corporation	2010-08-13	Substantially Equivalent	NBW	Clinical Chemistry
K011616	INDUO BLOOD GLUCOSE METER	Inverness Medical Innovations, Inc.	2001-06-21	Substantially Equivalent	NBW	Clinical Chemistry
K062058	ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; REAGENT STRIP, MODEL 7080	Bayer Healthcare	2006-09-11	Substantially Equivalent	NBW	Clinical Chemistry
K030531	MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP AND THE BD PARADIGM LINK GLUCOSE METER	Minimed, Inc.	2003-06-17	Substantially Equivalent	LZG	General Hospital
K904081	GLUCOMETER QA BLOOD GLUCOSE METER AND GLUCOFILM	Heraeus Kulzer, Inc.	1990-12-26	Substantially Equivalent	CGA	Clinical Chemistry
K112356	GLUCOSE METER-CHECK CONTROL SOLUTION FOR AGAMATRIX WAVESENSE	Bionostics, Inc.	2011-09-19	Substantially Equivalent	JJX	Clinical Chemistry
K926361	GLUCOMETER ENCORE QA BLOOD GLUCOSE METER	Heraeus Kulzer, Inc.	1993-06-24	Substantially Equivalent	CFR	Clinical Chemistry
K130265	CONTOUR NEXT EZ BLOOD GLUCOSE METER	Bayer Healthcare, LLC	2014-06-23	Substantially Equivalent	NBW	Clinical Chemistry
K123966	GLUCOSE METER-CHECK SOLUTION FOR BAYER	Bionostics, Inc.	2013-01-25	Substantially Equivalent	JJX	Clinical Chemistry
K103396	COOL BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE METER, COOL CONTROL SOLUTION	I-Sens, Inc.	2011-09-27	Substantially Equivalent	NBW	Clinical Chemistry
K131136	GLUCOSE METER-CHECK SOLUTION FOR TAIDOC	Bionostics, Inc.	2013-05-31	Substantially Equivalent	JJX	Clinical Chemistry
K984006	GLUCOMETER ELITE XL BLOOD GLUCOSE METER	Bayer Corp.	1999-03-18	Substantially Equivalent	CGA	Clinical Chemistry
K110587	CONTOUR LINK BLOOD GLUCOSE METER, CONTOUR BLOOD GLUCOSE TEST STRIPS, CONTOUR CONTROL SOLUTION (HIGH, NORMAL, LOW)	Bayer Healthcare, LLC	2012-03-28	Substantially Equivalent	LFR	Clinical Chemistry
K081403	GLUCOSE METER-CHECK CONTROL SOLUTION FOR ROCHE ACCU-CHEK	Bionostics, Inc.	2008-07-25	Substantially Equivalent	JJX	Clinical Chemistry
K040670	MODIFICATION TO TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, TEST STRIPS AND GLUCOSE CONTROL	Home Diagnostics, Inc.	2004-03-25	Substantially Equivalent	NBW	Clinical Chemistry
K964630	GLUCOMETER ELITE BLOOD GLUCOSE METER	Bayer Corp.	1997-02-10	Substantially Equivalent	CGA	Clinical Chemistry
K993128	HEALTHBUDDY WITH DEVICE CONNECT [GLUCOSE METER]	Health Hero Network, Inc.	1999-11-23	Substantially Equivalent	CGA	Clinical Chemistry
K123851	GLUCOSE METER-CHECK SOLUTION FOR ROCHE ACCU-CHEK	Bionostics, Inc.	2013-02-14	Substantially Equivalent	JJX	Clinical Chemistry
K024062	ASCENSIA BREEZE BLOOD GLUCOSE METER	Bayer Corp.	2003-03-03	Substantially Equivalent	CGA	Clinical Chemistry
K934898	GLUCOMETER QA BLOOD GLUCOSE METER MODIFICATION	Heraeus Kulzer, Inc.	1993-12-07	Substantially Equivalent	CGA	Clinical Chemistry
K111669	FREESTYLE GLUCOSE METER INCORPORATED INTO THE OMNIPOD INSULIN MANAGEMENT SYSTEMS	Insulet Corporation	2011-12-15	Substantially Equivalent	LZG	General Hospital
K062323	DELTEC COZMO INSULIN INFUSION PUMP WITH COZMONITOR BLOOD GLUCOSE METER, MODELS 21-1815, 21-1816, 21-1817	Smiths Medical MD, Inc.	2006-11-01	Substantially Equivalent	LZG	General Hospital
K120759	CARESENS N MINI BLOOD GLUCOSE MONITORING SYSTEM, MINI BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIP, CONTROL SOLUTION	I-Sens, Inc.	2012-06-05	Substantially Equivalent	CGA	Clinical Chemistry
K091820	CONTOUR USB BLOOD GLUCOSE METER, GLUCOSE TEST STRIPS; GLUCOFACTS DELUX DIABETES MANAGEMENT SYSTEM	Bayer Healthcare	2009-08-26	Substantially Equivalent	NBW	Clinical Chemistry
K120351	CARESENS N POP BLOOD GLUCOSE MONITORING SYSTEM CARESENS N POP BLOOD GLUCOSE METER CARESENS N BLOOD GLUCOSE TEST STRIP CA	I-Sens, Inc.	2012-05-03	Substantially Equivalent	NBW	Clinical Chemistry
K032657	TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIPS, AND GLUCOSE CONTROL SOLUTIONS (LOW AND HIGH)	Home Diagnostics, Inc.	2004-03-24	Substantially Equivalent	NBW	Clinical Chemistry
K897015	GLUCOMETER GX BLOOD GLUCOSE METER	Heraeus Kulzer, Inc.	1990-03-29	Substantially Equivalent	CGA	Clinical Chemistry
K971276	GLUCOMETER ENCORE QA+ BLOOD GLUCOSE METER	Bayer Corp.	1997-06-16	Substantially Equivalent	CFR	Clinical Chemistry
K090628	DIDGET BLOOD GLUCOSE METER, MODEL 6181; CONTOUR BLOOD GLUCOSE TEST STRIPS, MODEL 7080	Bayer Healthcare, LLC	2009-12-04	Substantially Equivalent	NBW	Clinical Chemistry
K990649	GLUCOMETER ELITE XL BLOOD GLUCOSE METER, GLUCOMETER ELITE BLOOD GLUCOSE TEST SYSTEMS	Bayer Corp.	1999-07-09	Substantially Equivalent	CGA	Clinical Chemistry
K040603	PARADIGM LINK BLOOD GLUCOSE METER	Becton, Dickinson & CO	2004-05-19	Substantially Equivalent	NBW	Clinical Chemistry
K031738	SMITHS MEDICAL INSULIN INFUSION PUMP WITH COZMONITOR GLUCOSE METER	Smiths Medical MD, Inc.	2004-05-27	Substantially Equivalent	LZG	General Hospital
K931188	CHECKMATE PLUS BLOOD GLUCOSE METER, TEST STRIP,ETC	Cascade Medical, Inc.	1993-05-26	Substantially Equivalent	CGA	Clinical Chemistry
K030703	TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER AND TRUE TRACK SMART SYSTEM BLOOD GLUCOSE TEST STRIPS	Home Diagnostics, Inc.	2003-07-11	Substantially Equivalent	NBW	Clinical Chemistry
K934900	GLUCOMETER ENCORE QA BLOOD GLUCOSE METER MODIFICATION	Heraeus Kulzer, Inc.	1993-12-07	Substantially Equivalent	CFR	Clinical Chemistry
K951537	GLUCOMETER ELITE M BLOOD GLUCOSE METER	Bayer Corp.	1995-07-14	Substantially Equivalent	CGA	Clinical Chemistry
K082395	GLUCOSE METER-CHECK CONTROL SOLUTION FOR BAYER ASCENSIA BLOOD GLUCOSE METER, MODEL: MC002	Bionostics, Inc.	2008-09-18	Substantially Equivalent	JJX	Clinical Chemistry
K110894	CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE METER	Bayer Healthcare	2012-03-28	Substantially Equivalent	LFR	Clinical Chemistry
K112352	GLUCOSE METER-CHECK CONTROL FOR NIPRO TRUERESULT	Bionostics, Inc.	2011-12-23	Substantially Equivalent	JJX	Clinical Chemistry
K121190	CONTOUR NEXT BLOOD GLUCOSE METER	Bayer Healthcare, LLC	2012-07-26	Substantially Equivalent	LFR	Clinical Chemistry
K113764	GLUCOSE METER-CHECK SOLUTION FOR INFOPIA	Bionostics, Inc.	2012-01-30	Substantially Equivalent	JJX	Clinical Chemistry
K931310	GLUCOMETER M+ BLOOD GLUCOSE METER	Heraeus Kulzer, Inc.	1993-06-25	Substantially Equivalent	CGA	Clinical Chemistry
K103278	ACURA PLUS BLOOD GLUCOSE MONITORING SYSTEM; ACURA PLUS BLOOD GLUCOSE METER; ACURA CONTROL SOLUTION	I-Sens, Inc.	2011-10-28	Substantially Equivalent	CGA	Clinical Chemistry
K060470	ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; ASCENSIA MICROFILL REAGENT STRIP, MODEL 7080	Bayer Healthcare	2006-04-12	Substantially Equivalent	NBW	Clinical Chemistry
K922888	ONE TOUCH IIB BLOOD GLUCOSE METER	Lifescan, Inc.	1992-09-15	Substantially Equivalent	CGA	Clinical Chemistry
K951058	GLUCOMETER ENCORE QA+ BLOOD GLUCOSE METER WORKSTATION	Heraeus Kulzer, Inc.	1995-06-01	Substantially Equivalent	CFR	Clinical Chemistry

数据随 FDA 官方库更新，仅供参考，不构成医学或法律建议；正式注册与报关请以 FDA 官方文件及最新法规为准。

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