ROCHE ABUSCREEN ONTRAK POS. REF. CONTROL-METHADONE

Drug Specific Control Materials

ROCHE DIAGNOSTIC SYSTEMS, INC.

The following data is part of a premarket notification filed by Roche Diagnostic Systems, Inc. with the FDA for Roche Abuscreen Ontrak Pos. Ref. Control-methadone.

Pre-market Notification Details

Device IDK930844
510k NumberK930844
Device Name:ROCHE ABUSCREEN ONTRAK POS. REF. CONTROL-METHADONE
ClassificationDrug Specific Control Materials
Applicant ROCHE DIAGNOSTIC SYSTEMS, INC. 1080 U.S. HIGHWAY 202 Branchburg,  NJ  08876 -3771
ContactCarol L Krieger
CorrespondentCarol L Krieger
ROCHE DIAGNOSTIC SYSTEMS, INC. 1080 U.S. HIGHWAY 202 Branchburg,  NJ  08876 -3771
Product CodeLAS  
CFR Regulation Number862.3280 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-02-18
Decision Date1994-01-27

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