Roche Diagnostics Corp. - FDA 510(k) Cleared Devices
264
Total
263
Cleared
1
Denied
264 devices
Cleared
Jun 01, 2000
ELECSYS ANTI-TPO CALCHECK
Immunology
64d
Cleared
May 18, 2000
THE CARDIAC READER SYSTEM
Chemistry
69d
Cleared
May 17, 2000
ELECSYS ANTI-THYROID PEROXIDASE ANTIBODY TEST SYSTEM
Immunology
119d
Cleared
Apr 27, 2000
ELECSYS THYROGLOBULIN CALCHECK
Immunology
29d
Cleared
Apr 26, 2000
ONTRAK TESTSTIK FOR METHAMPHETAMINE, CAT. 1986686
Toxicology
104d
Cleared
Apr 13, 2000
ONTRAK TESTSTIK 2 FOR COCAINE/THC, CAT. 1118579
Toxicology
126d
Cleared
Apr 07, 2000
ONTRAK TESTSTIK 3 FOR COCAINE/MORPHINE/THC,CAT. 1118595
Toxicology
120d
Cleared
Apr 05, 2000
COBAS INTEGRA REAGENT CASSETTE FOR RHEUMATOID FACTOR II
Immunology
48d
Cleared
Mar 21, 2000
ELECSYS CORTISOL CALCHECK
Chemistry
28d
Cleared
Mar 17, 2000
ELECSYS B-CROSSLAPS CALCHECK
Chemistry
71d
Cleared
Mar 07, 2000
ELECSYS CORTISOL TEST SYSTEM
Chemistry
39d
Cleared
Feb 23, 2000
ACCU-CHEK COMPLETE METER
Chemistry
19d
Cleared
Feb 23, 2000
ACCU-CHEK ADVANTAGE METER
Chemistry
19d
Cleared
Jan 27, 2000
ONTRAK TESTCUP 5 M2K, CAT. 11 1850 1
Toxicology
62d
Cleared
Jan 27, 2000
ONTRAK TESTSTIK FOR PCP, CAT. 07 6654 2
Toxicology
62d
Cleared
Jan 27, 2000
ONTRAK TESTCUP 5, CAT. 07 6481 7
Toxicology
62d
Cleared
Jan 14, 2000
ACT TEST CATRIDGES FOR COAGUCHEK PRO SYSTEM, ACT CONTROLS FOR COAGUCHEK PRO...
Hematology
143d
Cleared
Dec 20, 1999
ROCHE DIAGNOSTICS INFLUENZA A/B RAPID TEST
Microbiology
101d
Cleared
Dec 09, 1999
ACCU-CHEK SIMPLICITY SYSTEM
Chemistry
27d
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
Cleared
Nov 23, 1999
ROCHE COBAS INTEGRA OPIATES 300/2000
Toxicology
88d
Cleared
Nov 02, 1999
PTN TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, PTN CONTROLS FOR COAGUCHEK PRO...
Hematology
99d
Cleared
Sep 30, 1999
INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN ALC
Chemistry
190d
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