ONTRAK TESTCUP AMPHETAMINES

Enzyme Immunoassay, Amphetamine

ROCHE DIAGNOSTIC SYSTEMS, INC.

The following data is part of a premarket notification filed by Roche Diagnostic Systems, Inc. with the FDA for Ontrak Testcup Amphetamines.

Pre-market Notification Details

Device IDK962411
510k NumberK962411
Device Name:ONTRAK TESTCUP AMPHETAMINES
ClassificationEnzyme Immunoassay, Amphetamine
Applicant ROCHE DIAGNOSTIC SYSTEMS, INC. BRANCHBURG TOWNSHIP 1080 U.S. HIGHWAY 202 Somerville,  NJ  08876 -3771
ContactMaria Feijoo
CorrespondentMaria Feijoo
ROCHE DIAGNOSTIC SYSTEMS, INC. BRANCHBURG TOWNSHIP 1080 U.S. HIGHWAY 202 Somerville,  NJ  08876 -3771
Product CodeDKZ  
CFR Regulation Number862.3100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-06-21
Decision Date1996-10-07

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