QUINIDINE ENZYME IMMUNOASSAY

Enzyme Immunoassay, Quinidine

DIAGNOSTIC REAGENTS, INC.

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

Pre-market Notification Details

Device IDK964212
510k NumberK964212
Device Name:QUINIDINE ENZYME IMMUNOASSAY
ClassificationEnzyme Immunoassay, Quinidine
Applicant DIAGNOSTIC REAGENTS, INC. 601 CALIFORNIA AVE. Sunnyvale,  CA  94086
ContactYuh-geng Tsay
CorrespondentYuh-geng Tsay
DIAGNOSTIC REAGENTS, INC. 601 CALIFORNIA AVE. Sunnyvale,  CA  94086
Product CodeLBZ  
CFR Regulation Number862.3320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-10-22
Decision Date1996-12-18

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