BARBITURATE EIA TEST

Enzyme Immunoassay, Barbiturate

DIAGNOSTIC REAGENTS, INC.

The following data is part of a premarket notification filed by Diagnostic Reagents, Inc. with the FDA for Barbiturate Eia Test.

Pre-market Notification Details

Device IDK925491
510k NumberK925491
Device Name:BARBITURATE EIA TEST
ClassificationEnzyme Immunoassay, Barbiturate
Applicant DIAGNOSTIC REAGENTS, INC. 110 PIONEER WAY Mountain View,  CA  94041
ContactYuh-geng Tsay
CorrespondentYuh-geng Tsay
DIAGNOSTIC REAGENTS, INC. 110 PIONEER WAY Mountain View,  CA  94041
Product CodeDIS  
CFR Regulation Number862.3150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-11-02
Decision Date1992-12-30

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