PRIMIDONE EIA TEST

Radioimmunoassay, Amphetamine

DIAGNOSTIC REAGENTS, INC.

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

Pre-market Notification Details

Device IDK960526
510k NumberK960526
Device Name:PRIMIDONE EIA TEST
ClassificationRadioimmunoassay, Amphetamine
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 CodeDJP  
CFR Regulation Number862.3100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-02-06
Decision Date1996-03-18

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