Bayer Healthcare, LLC - FDA 510(k) Cleared Devices
Recent clearances: ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)
46
Total
46
Cleared
0
Denied
FDA 510(k) Regulatory Record - Bayer Healthcare, LLC Chemistry ✕
38 devices
Cleared
Jun 23, 2014
CONTOUR NEXT EZ BLOOD GLUCOSE METER
Chemistry
504d
Cleared
Jul 26, 2012
CONTOUR NEXT BLOOD GLUCOSE METER
Chemistry
98d
Cleared
Mar 28, 2012
CONTOUR LINK BLOOD GLUCOSE METER, CONTOUR BLOOD GLUCOSE TEST STRIPS, CONTOUR...
Chemistry
393d
Cleared
Mar 12, 2010
DIDGET WORLD REPORTS
Chemistry
80d
Cleared
Dec 04, 2009
DIDGET BLOOD GLUCOSE METER, MODEL 6181
Chemistry
270d
Cleared
May 14, 2009
A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT,...
Chemistry
85d
Cleared
Oct 08, 2008
GLUCOFACTS EXPRESS DIABETES MANAGEMENT SOFTWARE
Chemistry
41d
Cleared
Dec 07, 2007
ADVIA CHEMISTRY TOTAL BILIRUBIN_2
Chemistry
345d
Cleared
Dec 28, 2006
CLINITEK ADVANTUS, MODEL 1420
Chemistry
59d
Cleared
Nov 22, 2006
ASCENSIA BREEZE 2 BLOOD GLUCOSE MONITORING SYSTEM
Chemistry
104d
Cleared
Dec 30, 2005
TNL-ULTRA ASSAY FOR THE ADVIA CENTAUR SYSTEM
Chemistry
65d
Cleared
Dec 14, 2005
TROPONIN I ULTRA ASSAY AND CALIBRATOR FOR THE ADVIA IMS SYSTEM
Chemistry
92d
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