Medical Device Manufacturer · US , Elkhart , IN

Bayer Corp.

96 submissions · 96 cleared · Since 1989
96
Total
96
Cleared
0
Denied

Bayer Corp. — FDA 510(k) Submissions

Bayer Corp. has submitted 96 FDA 510(k) premarket notifications since 1989, of which 96 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Glucose Oxidase, Glucose, Prostate-specific Antigen (psa) For Management Of Prostate Cancers, Indicator Method, Protein Or Albumin (urinary, Non-quant.), Immunoassay Method, Troponin Subunit, System, Test, Blood Glucose, Over The Counter . Use the specialty filter in the sidebar to narrow results.

96 devices
1–25 of 96
ASCENSIA BREEZE BLOOD GLUCOSE METER
K024062 · CGA Glucose Oxidase, Glucose · Chemistry
Mar 2003 84d
BAYER DIAGNOSTICS CLINITEST PREGNANCY TEST
K023944 · JHI Visual, Pregnancy Hcg,... · Chemistry
Feb 2003 77d
BAYER ADVIA CENTAUR HER-2/NEU ASSAY
K024017 · NCW System, Test, Her-2/neu,... · Immunology
Jan 2003 57d
ASCENSIA GLUCOFACTS; ASCENSIA GLUCOFACTS PROFESSIONAL
K024234 · NBW System, Test, Blood... · Chemistry
Jan 2003 31d
COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM
K022288 · LTJ Prostate-specific Antigen... · Immunology
Dec 2002 155d
ASCENSIA DEX 2 DIABETES CARE SYSTEM
K023584 · NBW System, Test, Blood... · Chemistry
Nov 2002 26d
CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM
K020828 · LTK Test, Epithelial Ovarian... · Immunology
Jul 2002 132d
CLINITEK ATLAS PRO 12 REAGENT PAK SYSTEM
K021428 · JFY Enzymatic Method, Creatinine · Chemistry
Jul 2002 63d
ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAY
K020806 · LOJ Kit,... · Immunology
Mar 2002 15d
CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
K013568 · DHX System, Test,... · Immunology
Dec 2001 56d
BAYER ADVIA IMS SYSTEM; C-REACTIVE PROTEIN SYSTEM
K012337 · DCN System, Test, C-reactive... · Chemistry
Dec 2001 135d
ADVIA 1650 GLUCOSE HEXOKINASE 11 ASSAY
K011963 · CFR Hexokinase, Glucose · Chemistry
Nov 2001 151d
ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAY
K013272 · KLS Enzyme Immunoassay,... · Chemistry
Oct 2001 24d
ACS: 180 AND ADVIA CENTAUR ANTI-THYROGLOBULIN IMMUNOASSAYS
K012777 · JZO System, Test, Thyroid... · Immunology
Oct 2001 63d
BAYER ADVIA SYSTEM; UNSATURATED IRON BINDING CAPACITY (UIBC)
K012340 · JMO Ferrozine (colorimetric)... · Chemistry
Oct 2001 69d
GLUCOMETER DEX TEST SENSOR
K012205 · NBW System, Test, Blood... · Chemistry
Sep 2001 58d
BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGM ASSAY
K010755 · LGD Enzyme Linked... · Microbiology
Aug 2001 160d
BAYER DIAGNOSTICS ADVIA CENTAUR RUBELLA IGM ASSAY
K010668 · LFX Enzyme Linked... · Microbiology
Jul 2001 121d
ADVIA CENTAUR RUBELLA IGG ASSAY
K003412 · LFX Enzyme Linked... · Microbiology
Apr 2001 162d
BAYER ADVIA IMS SYSTEM
K010201 · MMI Immunoassay Method,... · Chemistry
Mar 2001 66d
ADVIA 120 HEMATOLOGY
K003796 · GKZ Counter, Differential Cell · Hematology
Feb 2001 59d
BAYER RAPIDPOINT 400 SYSTEM
K002738 · CHL Electrode Measurement,... · Chemistry
Dec 2000 109d
ADVIA: CENTAUR AND ACS: 180 CPSA ASSAY
K002376 · LTJ Prostate-specific Antigen... · Immunology
Oct 2000 83d
BAYER IMMUNO 1 HER-2/NEU ASSAY
K992228 · NCW System, Test, Her-2/neu,... · Immunology
Sep 2000 455d
ADVIA IMS
K001344 · DIH Colorimetry, Cholinesterase · Chemistry
Jun 2000 60d

Looking for a specific device from Bayer Corp.? Search by device name or K-number.

Search all Bayer Corp. devices
Filters