COCAINE METABOLITE INTERCEPT MICRO-PLATE EIA

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 Cocaine Metabolite Intercept Micro-plate Eia.

Pre-market Notification Details

Device IDK001197
510k NumberK001197
Device Name:COCAINE METABOLITE INTERCEPT MICRO-PLATE EIA
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)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-04-11
Decision Date2000-05-11

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00608337000313 K001197 000
00608337000306 K001197 000
00608337000290 K001197 000

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