Search FDA 510(k) Devices
4,872 clearances indexed · Search by device name, K-number, manufacturer or product code
479
results for "Roche Diagnostics"
Cleared
May 18, 2000
THE CARDIAC READER SYSTEM
Roche Diagnostics Corp.
Chemistry
69d
Cleared
May 17, 2000
ELECSYS ANTI-THYROID PEROXIDASE ANTIBODY TEST SYSTEM
Roche Diagnostics Corp.
Immunology
119d
Cleared
Apr 27, 2000
ELECSYS THYROGLOBULIN CALCHECK
Roche Diagnostics Corp.
Immunology
29d
Cleared
Apr 26, 2000
ONTRAK TESTSTIK FOR METHAMPHETAMINE, CAT. 1986686
Roche Diagnostics Corp.
Toxicology
104d
Cleared
Apr 13, 2000
ONTRAK TESTSTIK 2 FOR COCAINE/THC, CAT. 1118579
Roche Diagnostics Corp.
Toxicology
126d
Cleared
Apr 07, 2000
ONTRAK TESTSTIK 3 FOR COCAINE/MORPHINE/THC,CAT. 1118595
Roche Diagnostics Corp.
Toxicology
120d
Cleared
Apr 05, 2000
COBAS INTEGRA REAGENT CASSETTE FOR RHEUMATOID FACTOR II
Roche Diagnostics Corp.
Immunology
48d
Cleared
Mar 21, 2000
ELECSYS CORTISOL CALCHECK
Roche Diagnostics Corp.
Chemistry
28d
Cleared
Mar 17, 2000
ELECSYS B-CROSSLAPS CALCHECK
Roche Diagnostics Corp.
Chemistry
71d
Cleared
Mar 07, 2000
ELECSYS CORTISOL TEST SYSTEM
Roche Diagnostics Corp.
Chemistry
39d
Cleared
Feb 23, 2000
ACCU-CHEK ADVANTAGE METER
Roche Diagnostics Corp.
Chemistry
19d
Cleared
Feb 23, 2000
ACCU-CHEK COMPLETE METER
Roche Diagnostics Corp.
Chemistry
19d
Cleared
Jan 27, 2000
ONTRAK TESTCUP 5, CAT. 07 6481 7
Roche Diagnostics Corp.
Toxicology
62d
Cleared
Jan 27, 2000
ONTRAK TESTSTIK FOR PCP, CAT. 07 6654 2
Roche Diagnostics Corp.
Toxicology
62d
Cleared
Jan 27, 2000
ONTRAK TESTCUP 5 M2K, CAT. 11 1850 1
Roche Diagnostics Corp.
Toxicology
62d
Cleared
Jan 14, 2000
ACT TEST CATRIDGES FOR COAGUCHEK PRO SYSTEM, ACT CONTROLS FOR COAGUCHEK PRO...
Roche Diagnostics Corp.
Hematology
143d
Cleared
Dec 20, 1999
ROCHE DIAGNOSTICS INFLUENZA A/B RAPID TEST
Roche Diagnostics Corp.
Microbiology
101d
Cleared
Dec 09, 1999
ACCU-CHEK SIMPLICITY SYSTEM
Roche Diagnostics Corp.
Chemistry
27d
Cleared
Nov 30, 1999
ELECSYS PARATHYROID HORMONE CALCHECK
Roche Diagnostics Corp.
Immunology
33d
Cleared
Nov 24, 1999
PRECINORM UNIVERSAL PLUS AND PRECIPATH UNIVERSAL PLUS CONTROL SERA
Roche Diagnostics Corp.
Immunology
49d
Cleared
Nov 24, 1999
PRECINORM UNIVERSAL AND PRECIPATH UNIVERSAL CONTROL SERA
Roche Diagnostics Corp.
Immunology
86d
Cleared
Nov 23, 1999
ROCHE COBAS INTEGRA OPIATES 300/2000
Roche Diagnostics Corp.
Toxicology
88d
Cleared
Nov 02, 1999
PTN TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, PTN CONTROLS FOR COAGUCHEK PRO...
Roche Diagnostics Corp.
Hematology
99d
Cleared
Sep 30, 1999
INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN ALC
Roche Diagnostics Corp.
Chemistry
190d