PHENOBARBITAL ENZYME IMMUNOASSAY

Enzyme Immunoassay, Phenobarbital

DIAGNOSTIC REAGENTS, INC.

The following data is part of a premarket notification filed by Diagnostic Reagents, Inc. with the FDA for Phenobarbital Enzyme Immunoassay.

Pre-market Notification Details

Device IDK946210
510k NumberK946210
Device Name:PHENOBARBITAL ENZYME IMMUNOASSAY
ClassificationEnzyme Immunoassay, Phenobarbital
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 CodeDLZ  
CFR Regulation Number862.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-12-21
Decision Date1995-02-10

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