AUTO-LYTE COCAINE METABOLITE EIA, MODEL # 1222U

Enzyme Immunoassay, Cocaine And Cocaine Metabolites

ORASURE TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Orasure Technologies, Inc. with the FDA for Auto-lyte Cocaine Metabolite Eia, Model # 1222u.

Pre-market Notification Details

Device IDK982759
510k NumberK982759
Device Name:AUTO-LYTE COCAINE METABOLITE EIA, MODEL # 1222U
ClassificationEnzyme Immunoassay, Cocaine And Cocaine Metabolites
Applicant ORASURE TECHNOLOGIES, INC. 1745 EATON AVE. Bethlehem,  PA  18018 -1799
ContactR. Sam Niedbala
CorrespondentR. Sam Niedbala
ORASURE TECHNOLOGIES, INC. 1745 EATON AVE. Bethlehem,  PA  18018 -1799
Product CodeDIO  
CFR Regulation Number862.3250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-08-06
Decision Date1998-11-20

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