AUTO-LYTE PCP EIA, MODEL #1254U

Enzyme Immunoassay, Phencyclidine

ORASURE TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Orasure Technologies, Inc. with the FDA for Auto-lyte Pcp Eia, Model #1254u.

Pre-market Notification Details

Device IDK982801
510k NumberK982801
Device Name:AUTO-LYTE PCP EIA, MODEL #1254U
ClassificationEnzyme Immunoassay, Phencyclidine
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 CodeLCM  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-08-10
Decision Date1998-11-04

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