Search FDA 510(k) Devices
4,872 clearances indexed · Search by device name, K-number, manufacturer or product code
264
results for "Roche Diagnostics Corp."
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
Cleared
Sep 28, 1999
ELECSYS PARATHYROID HORMONE TEST SYSTEM
Roche Diagnostics Corp.
Chemistry
49d
Cleared
Sep 24, 1999
ELECSYS ESTRADIOL CALSET II
Roche Diagnostics Corp.
Chemistry
21d
Cleared
Jul 22, 1999
COBAS INTEGRA ACETAMINOPHEN
Roche Diagnostics Corp.
Toxicology
73d
Cleared
Jul 22, 1999
COBAS INTEGRA AMIKACIN MAB
Roche Diagnostics Corp.
Toxicology
73d
Cleared
Jun 22, 1999
ROCHE COBAS INTEGRA SERUM BENZODIAZEPINES (SBENZ)
Roche Diagnostics Corp.
Toxicology
57d
Cleared
Jun 22, 1999
ROCHE COBAS INTEGRA SERUM BARBITURATES
Roche Diagnostics Corp.
Toxicology
57d
Cleared
Apr 15, 1999
ONTRAK TESTSTIK FOR MORPHINE 2000 (M2K)
Roche Diagnostics Corp.
Toxicology
65d
Cleared
Apr 15, 1999
ONTRAK TESTCUP M2K, MODEL CAT. 11 1849 8
Roche Diagnostics Corp.
Toxicology
65d
Cleared
Apr 14, 1999
INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN B
Roche Diagnostics Corp.
Chemistry
49d
Cleared
Apr 14, 1999
INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN A-1
Roche Diagnostics Corp.
Chemistry
49d
Cleared
Apr 13, 1999
ONTRAK TESTCUP-ER M2K
Roche Diagnostics Corp.
Toxicology
62d
Cleared
Mar 22, 1999
CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.)
Roche Diagnostics Corp.
Chemistry
38d
Cleared
Feb 26, 1999
ONTRAK TESTCUP M2K AND ONTRAK TESTSTIK POSITIVE CONTROL, MODEL 11 18544,...
Roche Diagnostics Corp.
Toxicology
18d
Cleared
Feb 23, 1999
ONTRAK TESTCUP-5 M2K
Roche Diagnostics Corp.
Toxicology
20d