Roche Diagnostic Systems, Inc. - FDA 510(k) Cleared Devices
296
Total
296
Cleared
0
Denied
296 devices
Cleared
Dec 21, 1995
ROCHE CONTROL SERUM P
Immunology
72d
Cleared
Dec 13, 1995
ONTRAJ TESTCUP COLLECTION/URINALYSIS PANEL
Toxicology
56d
Cleared
Oct 30, 1995
COBAS FP REAGENT APPLICATION FOR FREE VALPROIC ACID
Toxicology
139d
Cleared
Oct 25, 1995
ROCHE REAGENT FOR BUN
Chemistry
61d
Cleared
Oct 13, 1995
ROCHE COBAS MICROS HEMATOLOGY ANALYZER
Hematology
88d
Cleared
Sep 20, 1995
ROCHE CALIBRATOR SERUM
Chemistry
469d
Cleared
Sep 20, 1995
ABUSCREEN ONLINE CONTROLS
Toxicology
44d
Cleared
Sep 20, 1995
ABUSCREEN ONLINE DRUG FREE URINE
Toxicology
35d
Cleared
Sep 15, 1995
ROCHE AMMONIA/ETHANOL/CO2 CALIBRATOR
Chemistry
122d
Cleared
Sep 12, 1995
ROCHE COBAS-FP REAGENTS FOR VANCOMYCIN
Toxicology
47d
Cleared
Sep 08, 1995
ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES
Chemistry
155d
Cleared
Jul 31, 1995
COBAS-FP APPLICATION FOR FREE PHENYTOIN, COBAS-FP PHENYTOIN CALIBRATORS, &...
Chemistry
59d
Cleared
Jun 01, 1995
ROCHE ABUSCREEN ONLINE FOR OPIATES 1000 TEST KIT-2000 NG/ML CUTOFF OLYMPUS...
Toxicology
70d
Cleared
Apr 21, 1995
COBAS CORE FREE T3 EIA
Chemistry
338d
Cleared
Apr 05, 1995
ROCHE ABUSCREEN ONLINE FOR METHAQUALONE
Toxicology
163d
Cleared
Mar 09, 1995
COBAS(R)-FP REAGENTS FOR GENTAMICIN AND COBAS(R)-FP GENTAMICIN CALIBRATORS
Toxicology
119d
Cleared
Feb 07, 1995
ROCHE-TDM ONLEIN(TM) CONTROLS
Toxicology
54d
Cleared
Jan 25, 1995
ABUSCREEN ONTRAK POSITIVE CONTROL
Toxicology
187d
Cleared
Jan 25, 1995
ABUSCREEN ONLINE(R) CALIBRATORS
Toxicology
50d
Cleared
Dec 09, 1994
ABUSCREEN ONLINE CONTROLS
Toxicology
46d
Cleared
Dec 09, 1994
ABUSCREEN ONLINE PROPOXPHENE
Toxicology
46d
Cleared
Dec 02, 1994
COBAS(R)-FP REAGENT FOR PROCAINAMIDE/CALIBRATOR
Toxicology
169d
Cleared
Dec 02, 1994
ONTRAK TESTCUP COLLECTION/URINALYSIS PANEL FOR COCAINE, MORPHINE AND THC
Chemistry
93d
Cleared
Oct 31, 1994
ROCHE REAGENT
Chemistry
214d
Cleared
Oct 04, 1994
ROCHE AMMONIA (VARIOUS)
Chemistry
159d
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