Bayer Diagnostics Corp. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Bayer Diagnostics Corp. - FDA 510(k) Cleared Devices
32
Total
32
Cleared
0
Denied
Bayer Diagnostics Corp. has 32 FDA 510(k) cleared medical devices. Based in Medfield, US.
Historical record: 32 cleared submissions from 2000 to 2003. Primary specialty: Chemistry.
Browse the FDA 510(k) cleared devices submitted by Bayer Diagnostics Corp. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Bayer Diagnostics Corp.
32 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
Dec 24, 2002
AMMONIA ASSAY FOR THE ADVIA 1650
Immunology
36d
Cleared
Dec 17, 2002
PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
Immunology
167d
Cleared
Nov 27, 2002
CA 125 II ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM
Immunology
132d
Cleared
Nov 18, 2002
ETHANOL ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM
Chemistry
55d
Cleared
Nov 12, 2002
CA 15-3 ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
Immunology
132d