Roche Diagnostic Systems, Inc. - FDA 510(k) Cleared Devices

Cleared Nov 20, 1987

REVISED LABELING FOR CANNABINOIDS TEST KIT

K874269 · LDJ

Toxicology · 31d

Cleared Nov 13, 1987

REVISED LABELING FOR ABUSCREEN EIA BARBITURATE

K874210 · DIS

Toxicology · 28d

Cleared Nov 13, 1987

REVISED LABELING FOR BENZODIAZEPINE TEST KIT

K874265 · JXM

Toxicology · 24d

Cleared Nov 13, 1987

REVISED LABELING FOR BARBITURATE TEST KIT

K874266 · DIS

Toxicology · 24d

Cleared Nov 13, 1987

REVISED LABELING FOR PCP TEST KIT

K874267 · LCM

Toxicology · 24d

Cleared Nov 13, 1987

REVISED LABELING FOR MORPHINE TEST KIT

K874268 · DJG

Toxicology · 24d

Cleared Nov 13, 1987

REVISED LABELING FOR LSD TEST KIT

K874270 · DLB

Toxicology · 24d

Cleared Nov 13, 1987

REVISED LABELING FOR COCAINE/COCAINE META. TEST

K874271 · DIO

Toxicology · 24d

Cleared Nov 13, 1987

REVISED LABELING FOR METHAQUALONE TEST KIT

K874272 · KXS

Toxicology · 24d

Cleared Nov 13, 1987

REVISED LABELING FOR AMPHETAMINE TEST KIT

K874273 · DKZ

Toxicology · 24d

Cleared Nov 13, 1987

REVISED LABELING FOR AMPHETAMINE TEST KIT

K874274 · DKZ

Toxicology · 24d

Cleared Jul 21, 1987

COBAS FP REAGENTS FOR PHENO & COBAS FP PHENO CALI.

K872397 · LGQ

Toxicology · 29d

Cleared Jun 08, 1987

MODIFIED COBAS FP REAGENTS FOR NAPA AND CALIBRATOR

K871680 · LAN

Toxicology · 40d

Cleared Mar 24, 1987

ABUSCREEN RADIOIMMUNOASSAY FOR BENZODIAZEPINES

K870994 · JXM

Toxicology · 13d

Cleared Mar 16, 1987

COCAINE METABOLITE ROCHE(R) EIA

K863843 · DIO

Toxicology · 166d

Cleared Mar 16, 1987

MORPHINE ROCHE (R) EIA TEST

K864168 · DOE

Toxicology · 143d

Cleared Mar 16, 1987

ABUSCREEN (R) EIA CANNABINOIDS

K870377 · LDJ

Toxicology · 46d

Cleared Mar 16, 1987

ABUSCREEN (R) EIA BARBITURATE

K870378 · DIS

Toxicology · 46d

Cleared Apr 11, 1986

ABUSCREEN RADIOIMMUNOASSAY FOR LSD W/ REF STANDARD

K860525 · DLB

Toxicology · 59d

Cleared Oct 15, 1985

ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE-HIGH SP

K854009 · DJP

Toxicology · 15d

Cleared Aug 07, 1985

COBAS REAGENT FOR LIDOCAINE & CALIBRATORS

K853010 · KLR

Toxicology · 22d

Cleared Jul 09, 1985

COBAS FP REAGEN FOR PROCAINAMIDE & PRO CALIBRATOR

K852320 · LAR

Toxicology · 39d

Cleared Jun 25, 1985

COBAS FP REAGEN FOR AMIKACIN & AMIKACIN CALIBRATOR

K852317 · KLQ

Toxicology · 25d

Cleared Jun 25, 1985

COBAS FP REAGEN FOR PRIMIDONE & PRIMI CALIBRATORS

K852318 · LFT

Toxicology · 25d

Cleared Jun 25, 1985

COBAS FP REAGENTS FOR NAPA AND NAPA CALIBRATORS

K852319 · LAN

Toxicology · 25d