Medical Device Manufacturer · US , Medfield , MA

Bayer Diagnostics Corp. - FDA 510(k) Cleared Devices

32 submissions · 32 cleared · Since 2000

32

Total

32

Cleared

0

Denied

FDA 510(k) Regulatory Record - Bayer Diagnostics Corp. Chemistry ✕

16 devices

1-12 of 16

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