Roche Diagnostic Systems, Inc. - FDA 510(k) Cleared Devices
296
Total
296
Cleared
0
Denied
296 devices
Cleared
Feb 16, 1990
COBAS READY LDH REAGENT
Chemistry
109d
Cleared
Jan 26, 1990
ABUSCREEN ONTRAK FOR PHENCYCLIDINE (PCP)
Toxicology
112d
Cleared
Dec 19, 1989
COBAS READY
Chemistry
67d
Cleared
Dec 01, 1989
ISOSCREEN-CK CONFIRMATORY KIT
Chemistry
58d
Cleared
Oct 16, 1989
COBAS READY GLUCOSE REAGENT
Chemistry
34d
Cleared
Sep 05, 1989
ROCHE REAGENT FOR URIC ACID
Chemistry
88d
Cleared
Aug 31, 1989
ROCHO ISOMUNE - LD
Chemistry
84d
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 11, 1989
ROCHE REAGENT FOR TRIGLYCERIDES
Chemistry
70d
Cleared
Aug 03, 1989
COBAS FARA II CENTRIFUGAL ANALYZER
Chemistry
70d
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
Jul 20, 1989
COBAS FARA CENTRIFUGAL ANALYZER
Chemistry
66d
Cleared
May 22, 1989
ROCHE(R) CARDIOSCREEN-CK
Chemistry
68d
Cleared
Mar 31, 1989
ROCHE CHLORIDE ELECTRODE
Chemistry
57d
Cleared
Mar 31, 1989
ABUSCREEN FP BENZODIAZEPHINE REAGENT
Toxicology
9d
Cleared
Mar 22, 1989
COBAS MFC
Chemistry
85d
Cleared
Mar 16, 1989
ABUSCREEN FP FOR CANNABINOIDS
Toxicology
23d
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