Bayer Diagnostics Corp. - FDA 510(k) Cleared Devices
32
Total
32
Cleared
0
Denied
FDA 510(k) Regulatory Record - Bayer Diagnostics Corp. Immunology ✕
7 devices
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 12, 2002
CA 15-3 ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
Immunology
132d
Cleared
Oct 01, 2002
AFP ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
Immunology
203d
Cleared
Feb 28, 2002
CA 15-3 ASSAY FOR THE ADVIA CENTAUR SYSTEM
Immunology
218d
Cleared
Dec 05, 2000
BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR ANTI-TPO ASSAY
Immunology
46d