AUTO-LYTE BENZODIAZEPINES EIA MODEL NUMBER 1210U

Enzyme Immunoassay, Benzodiazepine

ORASURE TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Orasure Technologies, Inc. with the FDA for Auto-lyte Benzodiazepines Eia Model Number 1210u.

Pre-market Notification Details

Device IDK982831
510k NumberK982831
Device Name:AUTO-LYTE BENZODIAZEPINES EIA MODEL NUMBER 1210U
ClassificationEnzyme Immunoassay, Benzodiazepine
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 CodeJXM  
CFR Regulation Number862.3170 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-08-11
Decision Date1998-11-12

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