Roche Diagnostic Systems, Inc. - FDA 510(k) Cleared Devices
296
Total
296
Cleared
0
Denied
159 devices
Cleared
Jan 26, 1990
ABUSCREEN ONTRAK FOR PHENCYCLIDINE (PCP)
Toxicology
112d
Cleared
Aug 28, 1989
ABUSCREEN POSITIVE REFERENCE CONTROLS
Toxicology
39d
Cleared
Aug 21, 1989
ABUSCREEN TRI-LEVEL REFERENCE CONTROLS
Toxicology
32d
Cleared
Aug 15, 1989
COBAS-FP REAGENT FOR VALPROIC ACID & CALIBRATORS
Toxicology
148d
Cleared
Aug 15, 1989
ABUSCREEN RADIOIMMUNOASSAY FOR METHAMPHETAMINE
Toxicology
26d
Cleared
Aug 03, 1989
ABUSCREEN ONTRAK POS. REF. CONTROL FOR BARBITUATES
Toxicology
70d
Cleared
Aug 03, 1989
ABUSCREEN ONTRAK POS. REF. CONTROL FOR MORPHINE
Toxicology
70d
Cleared
Aug 03, 1989
ABUSCREEN ONTRAK POS. REF. CONTROL FOR AMPHETAMINE
Toxicology
70d
Cleared
Aug 03, 1989
ABUSCREEN ONTRAK POS. REFERENCE CONTROL FOR THC
Toxicology
70d
Cleared
Aug 03, 1989
ABUSCREEN ONTRAK POS. REF. CONTROL FOR COCAINE
Toxicology
70d
Cleared
Aug 03, 1989
ABUSCREEN ONTRAK POS.REF.CONTROL FOR PHENCYCLIDINE
Toxicology
70d
Cleared
Mar 31, 1989
ABUSCREEN FP BENZODIAZEPHINE REAGENT
Toxicology
9d
Cleared
Mar 16, 1989
ABUSCREEN FP FOR CANNABINOIDS
Toxicology
23d
Cleared
Mar 15, 1989
ABUSCREEN FP FOR PHENCYCLIDINE
Toxicology
22d
Cleared
Mar 15, 1989
ABUSCREEN FP BUFFER REAGENT
Toxicology
22d
Cleared
Mar 15, 1989
ABUSCREEN FP FOR MORPHINE
Toxicology
22d
Cleared
Mar 13, 1989
ABUSCREEN FP FOR COCAINE METABOLITE
Toxicology
20d
Cleared
Mar 10, 1989
ABUSCREEN FP FOR AMPHETAMINE
Toxicology
17d
Cleared
Mar 09, 1989
ABUSCREEN FP FOR BARBITURATES
Toxicology
16d
Cleared
Sep 02, 1988
ABUSCREEN(R) ONTRAK(TM) FOR MORPHINE
Toxicology
77d
Cleared
Jul 29, 1988
ABUSCREEN(R) ONTRAK(TM) FOR THC
Toxicology
92d
Cleared
Jul 29, 1988
ABUSCREEN(R) ONTRAK(TM) FOR COCAINE
Toxicology
92d
Cleared
Jul 29, 1988
ABUSCREEN(R) ONTRAK(TM) FOR AMPHETAMINES
Toxicology
92d
Cleared
Jul 28, 1988
ABUSCREEN(R) ONTRAK(TM) FOR BARBITURATES
Toxicology
91d
Cleared
Feb 16, 1988
ABUSCREEN(R) EIA AMPHETAMINE
Toxicology
84d
Looking for a specific device from Roche Diagnostic Systems, Inc.? Search by device name or K-number.
Search all Roche Diagnostic... devices