IMMULITE COCAINE METABOLITE

Enzyme Immunoassay, Cocaine And Cocaine Metabolites

DIAGNOSTIC PRODUCTS CORP.

The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite Cocaine Metabolite.

Pre-market Notification Details

Device IDK963918
510k NumberK963918
Device Name:IMMULITE COCAINE METABOLITE
ClassificationEnzyme Immunoassay, Cocaine And Cocaine Metabolites
Applicant DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles,  CA  90045 -5597
ContactEdward M Levine, Ph.d.
CorrespondentEdward M Levine, Ph.d.
DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles,  CA  90045 -5597
Product CodeDIO  
CFR Regulation Number862.3250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-09-30
Decision Date1997-04-08
Summary:summary

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