Roche Diagnostic Systems, Inc. - FDA 510(k) Cleared Devices
296
Total
296
Cleared
0
Denied
296 devices
Cleared
Nov 13, 1987
REVISED LABELING FOR METHAQUALONE TEST KIT
Toxicology
24d
Cleared
Nov 13, 1987
REVISED LABELING FOR AMPHETAMINE TEST KIT
Toxicology
24d
Cleared
Nov 13, 1987
REVISED LABELING FOR AMPHETAMINE TEST KIT
Toxicology
24d
Cleared
Oct 20, 1987
ISOMUNE-AMYLASE AND ISOMUNE-AMYLASE CONTROL
Chemistry
64d
Cleared
Jul 21, 1987
COBAS FP REAGENTS FOR PHENO & COBAS FP PHENO CALI.
Toxicology
29d
Cleared
Jun 08, 1987
MODIFIED COBAS FP REAGENTS FOR NAPA AND CALIBRATOR
Toxicology
40d
Cleared
May 28, 1987
COBAS FP REAGENTS FOR THEOPHYLLINE & CALIBRATORS
Chemistry
43d
Cleared
Mar 24, 1987
ABUSCREEN RADIOIMMUNOASSAY FOR BENZODIAZEPINES
Toxicology
13d
Cleared
Mar 16, 1987
COCAINE METABOLITE ROCHE(R) EIA
Toxicology
166d
Cleared
Mar 16, 1987
MORPHINE ROCHE (R) EIA TEST
Toxicology
143d
Cleared
Mar 16, 1987
ABUSCREEN (R) EIA CANNABINOIDS
Toxicology
46d
Cleared
Mar 16, 1987
ABUSCREEN (R) EIA BARBITURATE
Toxicology
46d
Cleared
Apr 11, 1986
ABUSCREEN RADIOIMMUNOASSAY FOR LSD W/ REF STANDARD
Toxicology
59d
Cleared
Mar 04, 1986
COBAS BACT ID TEST SYS, INDOLE SPOT TEST REAGENT
Microbiology
231d
Cleared
Oct 15, 1985
ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE-HIGH SP
Toxicology
15d
Cleared
Aug 07, 1985
COBAS REAGENT FOR LIDOCAINE & CALIBRATORS
Toxicology
22d
Cleared
Jul 12, 1985
ION-SPECIFIC ELECTRODE OPTION FOR COBAS FARA
Chemistry
31d
Cleared
Jul 09, 1985
COBAS FP REAGEN FOR PROCAINAMIDE & PRO CALIBRATOR
Toxicology
39d
Cleared
Jun 25, 1985
COBAS FP REAGEN FOR AMIKACIN & AMIKACIN CALIBRATOR
Toxicology
25d
Cleared
Jun 25, 1985
COBAS FP REAGEN FOR PRIMIDONE & PRIMI CALIBRATORS
Toxicology
25d
Cleared
Jun 25, 1985
COBAS FP REAGENTS FOR NAPA AND NAPA CALIBRATORS
Toxicology
25d
Cleared
May 10, 1985
COBAS CALIBRATOR SERUM
Chemistry
70d
Cleared
May 02, 1985
COBAS MIRA
Chemistry
41d
Cleared
Apr 22, 1985
SEPTI-CHEK SCHAEDLER MED. BLOOD CULTURE BOTTLE-ROC
Microbiology
26d
Cleared
Apr 22, 1985
SEPTI-CHEK TSB W/SUCROSE BLOOD CULTURE BOTTLE-ROCH
Microbiology
26d
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