Medical Device Manufacturer · US , Medfield , MA

Bayer Diagnostics Corp.

32 submissions · 32 cleared · Since 2000
32
Total
32
Cleared
0
Denied

Bayer Diagnostics Corp. — FDA 510(k) Submissions

Bayer Diagnostics Corp. has submitted 32 FDA 510(k) premarket notifications since 2000, of which 32 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Multi-analyte Controls, All Kinds (assayed), Enzymatic Method, Ammonia, System, Test, Immunological, Antigen, Tumor, Calibrator, Secondary, Counter, Differential Cell . Use the specialty filter in the sidebar to narrow results.

32 devices
1–12 of 32
BAYER SPECIAL CHEMISTRY CONTROLS
K033379 · JJY Multi-analyte Controls,... · Chemistry
Dec 2003 58d
BAYER SPECIAL CHEMISTRY CALIBRATORS
K033380 · JIX Calibrator, Multi-analyte... · Chemistry
Dec 2003 55d
BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEM
K033007 · KXT Enzyme Immunoassay, Digoxin · Chemistry
Nov 2003 49d
ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY
K031857 · DEM Alpha-1-antitrypsin,... · Chemistry
Sep 2003 80d
URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
K022096 · KNK Acid, Uric, Uricase... · Chemistry
Mar 2003 264d
BAYER LIGAND PLUS 1, 2, 3 CONTROLS
K030452 · JJY Multi-analyte Controls,... · Chemistry
Mar 2003 20d
ACID PHOSPHATASE ASSAY FOR THE ADVIA 1650
K023840 · CKB Acid Phosphatase,... · Chemistry
Jan 2003 50d
AMMONIA ASSAY FOR THE ADVIA 1650
K023841 · JIF Enzymatic Method, Ammonia · Immunology
Dec 2002 36d
PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
K022177 · LTJ Prostate-specific Antigen... · Immunology
Dec 2002 167d
CA 125 II ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM
K022329 · LTK Test, Epithelial Ovarian... · Immunology
Nov 2002 132d
ETHANOL ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM
K023184 · DIC Alcohol Dehydrogenase,... · Chemistry
Nov 2002 55d
CA 15-3 ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
K022178 · MOI System, Test,... · Immunology
Nov 2002 132d
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