LIDOCAINE EIA ASSAY

Enzyme Immunoassay, Lidocaine

DIAGNOSTIC REAGENTS, INC.

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

Pre-market Notification Details

Device IDK973102
510k NumberK973102
Device Name:LIDOCAINE EIA ASSAY
ClassificationEnzyme Immunoassay, Lidocaine
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 CodeKLR  
CFR Regulation Number862.3555 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-08-19
Decision Date1997-09-12

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