Bayer Healthcare, LLC

FDA 510(k) & PMA Approved Devices — 44 products

Total Devices44

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K171802	ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)	NUH	2018-03-07	View
510(k)	K121190	CONTOUR NEXT BLOOD GLUCOSE METER	LFR	2012-07-26	View
510(k)	K110587	CONTOUR LINK BLOOD GLUCOSE METER, CONTOUR BLOOD GLUCOSE TEST STRIPS, CONTOUR CONTROL SOLUTION (HIGH, NORMAL, LOW)	LFR	2012-03-28	View
510(k)	K093930	DIDGET WORLD REPORTS	NBW	2010-03-12	View
510(k)	K090628	DIDGET BLOOD GLUCOSE METER, MODEL 6181; CONTOUR BLOOD GLUCOSE TEST STRIPS, MODEL 7080	NBW	2009-12-04	View
510(k)	K090413	A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT, PROFESSIONAL USE) MODEL 3021, A1CNOW SELF CHEC	LCP	2009-05-14	View
510(k)	K082486	GLUCOFACTS EXPRESS DIABETES MANAGEMENT SOFTWARE	NBW	2008-10-08	View
510(k)	K063845	ADVIA CHEMISTRY TOTAL BILIRUBIN_2	JFM	2007-12-07	View
510(k)	K063276	CLINITEK ADVANTUS, MODEL 1420	JIL	2006-12-28	View
510(k)	K062347	ASCENSIA BREEZE 2 BLOOD GLUCOSE MONITORING SYSTEM	NBW	2006-11-22	View
510(k)	K061137	ADVIA IMS CPSA CONTROL	JJY	2006-07-06	View
510(k)	K061139	BAYER ADVIA IMS PSA CALIBRATOR AND ADVIA IMS CPSA CALIBRATORS	JIT	2006-07-06	View
510(k)	K053020	TNL-ULTRA ASSAY FOR THE ADVIA CENTAUR SYSTEM	MMI	2005-12-30	View
510(k)	K052503	TROPONIN I ULTRA ASSAY AND CALIBRATOR FOR THE ADVIA IMS SYSTEM	MMI	2005-12-14	View
510(k)	K051693	MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM	GKL	2005-12-07	View
510(k)	K052163	ADVIA IMS GLUCOSE ASSAY	CFR	2005-10-11	View
510(k)	K052242	ADVIA CHEMISTRY MICROALBUMIN CONTROLS	JJW	2005-10-03	View
510(k)	K051619	LIPOPROTEIN FOR MULTIPLE ANALYTES	JIX	2005-08-01	View
510(k)	K050374	ADVIA IMS LITHIUM ASSAY	NDW	2005-06-15	View
510(k)	K051265	ADVIA IMMUNO MODULAR SYSTEM (IMS) B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY	NBC	2005-06-13	View