Bayer Corp. - FDA 510(k) Cleared Devices
96
Total
96
Cleared
0
Denied
FDA 510(k) Regulatory Record - Bayer Corp. Immunology ✕
18 devices
Cleared
Jan 30, 2003
BAYER ADVIA CENTAUR HER-2/NEU ASSAY
Immunology
57d
Cleared
Dec 17, 2002
COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA...
Immunology
155d
Cleared
Jul 24, 2002
CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM
Immunology
132d
Cleared
Mar 27, 2002
ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAY
Immunology
15d
Cleared
Dec 21, 2001
CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
Immunology
56d
Cleared
Oct 22, 2001
ACS: 180 AND ADVIA CENTAUR ANTI-THYROGLOBULIN IMMUNOASSAYS
Immunology
63d
Cleared
Oct 26, 2000
ADVIA: CENTAUR AND ACS: 180 CPSA ASSAY
Immunology
83d
Cleared
Sep 29, 2000
BAYER IMMUNO 1 HER-2/NEU ASSAY
Immunology
455d
Cleared
Apr 13, 2000
BAYER PSA ASSAY
Immunology
120d
Cleared
Nov 09, 1999
ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM
Immunology
155d
Cleared
May 14, 1999
THE IMMUNO 1 CA 125 II ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO...
Immunology
205d
Cleared
Oct 22, 1998
BAYER IMMUNO 1 SYSTEM FERRITIN ASSAY
Immunology
79d
Cleared
Apr 23, 1998
THE COMPLEXED PSA ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
Immunology
83d
Cleared
Dec 01, 1997
THE CA 15-3 ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
Immunology
374d
Cleared
Oct 31, 1997
CPA 125 II ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM
Immunology
385d
Cleared
Sep 22, 1997
AFP ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
Immunology
83d
Cleared
May 29, 1997
B2 MICROGLOBULIN ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC...
Immunology
181d
Cleared
Aug 15, 1996
MYOGLOBIN ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM)
Immunology
58d