ABUSCREEN ONLINE(R) FOR COCAINE METABOLITE, MODIF

Enzyme Immunoassay, Cocaine And Cocaine Metabolites

ROCHE DIAGNOSTIC SYSTEMS, INC.

The following data is part of a premarket notification filed by Roche Diagnostic Systems, Inc. with the FDA for Abuscreen Online(r) For Cocaine Metabolite, Modif.

Pre-market Notification Details

Device IDK933053
510k NumberK933053
Device Name:ABUSCREEN ONLINE(R) FOR COCAINE METABOLITE, MODIF
ClassificationEnzyme Immunoassay, Cocaine And Cocaine Metabolites
Applicant ROCHE DIAGNOSTIC SYSTEMS, INC. 1080 U.S. HIGHWAY 202 Branchburg,  NJ  08876 -3771
ContactMaria Feijoo
CorrespondentMaria Feijoo
ROCHE DIAGNOSTIC SYSTEMS, INC. 1080 U.S. HIGHWAY 202 Branchburg,  NJ  08876 -3771
Product CodeDIO  
CFR Regulation Number862.3250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-05-26
Decision Date1993-08-30

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