Roche Diagnostic Systems, Inc. - FDA 510(k) Cleared Devices
296
Total
296
Cleared
0
Denied
159 devices
Cleared
Jun 13, 1996
ABISCREEN ONLINE FOR CANNABINOIDS - ES 50/100
Toxicology
48d
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
Sep 20, 1995
ABUSCREEN ONLINE CONTROLS
Toxicology
44d
Cleared
Sep 20, 1995
ABUSCREEN ONLINE DRUG FREE URINE
Toxicology
35d
Cleared
Sep 12, 1995
ROCHE COBAS-FP REAGENTS FOR VANCOMYCIN
Toxicology
47d
Cleared
Jun 01, 1995
ROCHE ABUSCREEN ONLINE FOR OPIATES 1000 TEST KIT-2000 NG/ML CUTOFF OLYMPUS...
Toxicology
70d
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
Aug 09, 1994
ROCHE ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE (HIGH CUT-OFF)
Toxicology
293d
Cleared
Jul 06, 1994
COBAS-FP QUINIDINE REAGENTS AND CALIBRATORS
Toxicology
104d
Cleared
Jun 13, 1994
COBAS-FP REAGENTS AND CALIBRATORS
Toxicology
68d
Cleared
Mar 11, 1994
COBAS-FP REAGENT FOR PHENOBARBITAL AND COBAS-FP PHENOBARBITAL CALIBRATORS
Toxicology
78d
Cleared
Mar 11, 1994
COBAS-FP REAGENT FOR PHENYTOIN AND COBA-FP PHENYTOIN CALIBRATORS
Toxicology
78d
Cleared
Jan 27, 1994
ROCHE ABUSCREEN ONTRAK POS. REF. CONTROL-METHADONE
Toxicology
343d
Cleared
Jan 25, 1994
ROCHE ABUSCREEN SAMPLE OXIDIZING REAGENT
Toxicology
96d
Cleared
Jan 03, 1994
ABUSCREEN ONLINE NEGATIVE CAL/CONTROL CAL PACK AND MIL CALIBRATION PACK
Toxicology
47d
Cleared
Dec 29, 1993
ABUSCREEN ONLINE LOW-CUTOFF CALIBRATORS
Toxicology
217d
Cleared
Sep 24, 1993
ROCHE ABUSCREEN ONLINE FOR METHADONE
Toxicology
213d
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