Roche Diagnostic Systems, Inc. - FDA 510(k) Cleared Devices
296
Total
296
Cleared
0
Denied
159 devices
Cleared
Sep 15, 1993
ABUSCREEN ONLINE(R) FOR AMPHETAMINES, MODIFIED
Toxicology
112d
Cleared
Aug 30, 1993
ABUSCREEN ONLINE(R) FOR COCAINE METABOLITE, MODIF
Toxicology
96d
Cleared
Aug 26, 1993
ABUSCREEN ONLINE LOW-CUTOFF CONTROLS
Toxicology
92d
Cleared
Aug 09, 1993
ABUSCREEN ONLINE BENZODIAZEPINES 300 CALIBRATOR
Toxicology
34d
Cleared
Aug 03, 1993
ABUSCREEN ONLINE(R) CALIBRATORS
Toxicology
152d
Cleared
Aug 03, 1993
ABUSCREEN ONLINE CONTROL
Toxicology
152d
Cleared
Jul 22, 1993
ROCHE ABUSCREEN TRI-LEVEL REFERENCE CONTROLS
Toxicology
55d
Cleared
Jul 22, 1993
ABUSCREEN CALIBRATION STANDARD
Toxicology
55d
Cleared
Apr 20, 1993
ROCHE ABUSCREEN ONTRAK FOR METHADONE
Toxicology
61d
Cleared
Feb 25, 1993
COBAS-FP TDM CONTROLS
Toxicology
37d
Cleared
Dec 28, 1992
ABUSCREEN ONLINE FOR COCAINE METABOLITE
Toxicology
137d
Cleared
Dec 03, 1992
COBAS-FP REAGENT FOR VALPROIC ACID AND CALIBRATORS
Toxicology
62d
Cleared
Aug 04, 1992
ROCHE ABUSCREEN ONLINNE CALIBRATORS
Toxicology
40d
Cleared
May 26, 1992
ABUSCREEN(R) ONLINE(TM) FOR AMPHETAMINES, MODIFIED
Toxicology
33d
Cleared
Mar 18, 1992
ABUSCREEN ONLINE FOR PHENCYCLIDINE
Toxicology
19d
Cleared
Jan 28, 1992
ABUSCREEN ONLINE CANNABINOIDS POSITIVE CONTROL
Toxicology
50d
Cleared
Nov 19, 1991
ABUSCREEN(R) ONTRAK(R) POSITIVE REFERENCE CONTROL
Toxicology
26d
Cleared
Nov 01, 1991
ABUSCREEN(R) RADIOIMMUNOASSAY FOR METHAMPHE/AMPHET
Toxicology
63d
Cleared
Nov 01, 1991
ABUSCREEN(R) ONLINE(TM) FOR BENZODIAZEPINES
Toxicology
23d
Cleared
Oct 30, 1991
ABUSCREEN(R) ONLINE(TM) FOR BARBITURATES
Toxicology
23d
Cleared
Sep 27, 1991
ABUSCREEN RADIOIMMUNOASSAY FOR METHAMPHETAMINE
Toxicology
98d
Cleared
Sep 25, 1991
ABUSCREEN(R) ONLINE(TM) FOR THC(50/100)(100TEST KT
Toxicology
62d
Cleared
Sep 10, 1991
ABUSCREEN(R) RADIOIMMUN FOR COCAINE METABOLITE
Toxicology
25d
Cleared
Aug 26, 1991
ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE
Toxicology
66d
Cleared
Aug 26, 1991
ABUSCREEN(R) ONLINE(TM) CALIBRATORS
Toxicology
34d
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