Bayer Healthcare, LLC - FDA 510(k) Cleared Devices
46
Total
46
Cleared
0
Denied
46 devices
Cleared
Feb 08, 2005
ADVIA IMS CARBAMAZEPINE METHOD
Chemistry
119d
Cleared
Dec 22, 2004
ASCENSIA BRIO BLOOD GLUCOSE MONITORING SYSTEM
Chemistry
37d
Cleared
Dec 22, 2004
ASCENSIA ELITE DIABETES CARE SYSTEM
Chemistry
21d
Cleared
Sep 17, 2004
BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM
Hematology
28d
Cleared
Jul 02, 2004
MODIFICATION TO BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER
Chemistry
63d
Cleared
Jun 14, 2004
ACS:180 AND ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAYS
Chemistry
117d
Cleared
Feb 13, 2004
BAYER SPECIFIC PROTEIN REFERENCE SERUM
Chemistry
71d
Cleared
Dec 23, 2003
CLINITEST HCG PREGNANCY TEST
Chemistry
125d
Cleared
Dec 19, 2003
BAYER CLINITEK STATUS ANALYZER
Chemistry
178d
Cleared
Dec 17, 2003
BAYER RAPIDLAB 1200 SYSTEM
Chemistry
212d
Cleared
Sep 09, 2003
BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER
Chemistry
25d
Cleared
Sep 08, 2003
ADVIA 60 HEMATOLOGY ANALYZER
Hematology
24d
Cleared
Aug 06, 2003
TOX AMMONIA CALIBRATOR
Chemistry
68d
Cleared
Jun 25, 2003
BAYER ADVIA CHEMISTRY SPECIAL CHEMISTRY CONTROL
Chemistry
29d
Cleared
Jun 25, 2003
LIPOPROTEIN CALIBRATOR
Chemistry
26d
Cleared
Jun 24, 2003
BAYER ADVIA CENTAUR CA 19-9 ASSAY
Immunology
53d
Cleared
Jun 23, 2003
ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY
Chemistry
83d
Cleared
Apr 10, 2003
BAYER ADVIA 1650 SPECIAL CHEMISTRY CALIBRATOR
Chemistry
28d
Cleared
Apr 09, 2003
BAYER ADVIA 1650 SPECIAL CHEMISTRY CONTROL
Chemistry
27d
Cleared
Jan 31, 2003
SETPOINT CHEMISTRY CALIBRATOR
Chemistry
14d
Cleared
Jan 24, 2003
ADVIA CENTAUR AND ACS:180 LIQUID CARDIAC MARKERS 1, 2, 3
Chemistry
14d