STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL 1108I

Enzyme Immunoassay, Barbiturate

ORASURE TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Orasure Technologies, Inc. with the FDA for Stc Barbiturates Intercept Micro-plate Eia, Model 1108i.

Pre-market Notification Details

Device IDK001976
510k NumberK001976
Device Name:STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL 1108I
ClassificationEnzyme Immunoassay, Barbiturate
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 CodeDIS  
CFR Regulation Number862.3150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-06-29
Decision Date2000-12-06

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00608337000221 K001976 000
00608337000214 K001976 000
00608337000207 K001976 000

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