Roche Diagnostics Corp. - FDA 510(k) Cleared Devices
264
Total
263
Cleared
1
Denied
38 devices
Cleared
Mar 28, 2001
ELECSYSCA 15-3 II ASSAY
Immunology
29d
Cleared
Jan 12, 2001
CA 125 II CALCHECK
Immunology
21d
Cleared
Jan 12, 2001
ELECSYS CA 125 II CALSET
Immunology
21d
Cleared
Oct 23, 2000
ELECSYS CA 15-3 TEST SYSTEM
Immunology
166d
Cleared
Sep 05, 2000
TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM
Immunology
14d
Cleared
Aug 10, 2000
ELECSYS CA 15-3 CALCHECK
Immunology
8d
Cleared
Jun 01, 2000
ELECSYS ANTI-TPO CALCHECK
Immunology
64d
Cleared
May 17, 2000
ELECSYS ANTI-THYROID PEROXIDASE ANTIBODY TEST SYSTEM
Immunology
119d
Cleared
Apr 27, 2000
ELECSYS THYROGLOBULIN CALCHECK
Immunology
29d
Cleared
Apr 05, 2000
COBAS INTEGRA REAGENT CASSETTE FOR RHEUMATOID FACTOR II
Immunology
48d
Cleared
Nov 30, 1999
ELECSYS PARATHYROID HORMONE CALCHECK
Immunology
33d
Cleared
Nov 24, 1999
PRECINORM UNIVERSAL AND PRECIPATH UNIVERSAL CONTROL SERA
Immunology
86d
Cleared
Nov 24, 1999
PRECINORM UNIVERSAL PLUS AND PRECIPATH UNIVERSAL PLUS CONTROL SERA
Immunology
49d