Bayer Diagnostics Corp. - FDA 510(k) Cleared Devices
32
Total
32
Cleared
0
Denied
FDA 510(k) Regulatory Record - Bayer Diagnostics Corp. Chemistry ✕
16 devices
Cleared
Dec 19, 2003
BAYER SPECIAL CHEMISTRY CONTROLS
Chemistry
58d
Cleared
Dec 16, 2003
BAYER SPECIAL CHEMISTRY CALIBRATORS
Chemistry
55d
Cleared
Nov 14, 2003
BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEM
Chemistry
49d
Cleared
Sep 04, 2003
ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY
Chemistry
80d
Cleared
Mar 18, 2003
URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
Chemistry
264d
Cleared
Mar 03, 2003
BAYER LIGAND PLUS 1, 2, 3 CONTROLS
Chemistry
20d
Cleared
Jan 07, 2003
ACID PHOSPHATASE ASSAY FOR THE ADVIA 1650
Chemistry
50d
Cleared
Nov 18, 2002
ETHANOL ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM
Chemistry
55d
Cleared
Jul 13, 2002
AMMONIA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
Chemistry
94d
Cleared
Jun 27, 2002
ADVIA CENTAUR AND ACS:180 C-PEPTIDE CALIBRATOR
Chemistry
48d
Cleared
Jun 27, 2002
ADVIA CANTAUR AND ACS:180 INSULIN CALIBRATOR
Chemistry
48d
Cleared
Mar 15, 2002
ACS:180 AND ADVIA CENTAUR IPTH IMMUNOASSAY
Chemistry
52d
Cleared
Jan 18, 2002
ADVIA 1650 CHOLINESTERASE ASSAY
Chemistry
66d
Cleared
Dec 21, 2001
ACS 180 HOMOCYSTEINE ASSAY
Chemistry
51d
Cleared
Dec 18, 2001
ADVIA CENTAUR HOMOCYSTEINE ASSAY
Chemistry
64d
Cleared
Feb 05, 2001
ADVIA CENTAUR AND ACS: 180 FOLATE IMMUNOASSAY
Chemistry
31d