PHENYTION EIA TEST

Enzyme Immunoassay, Diphenylhydantoin

DIAGNOSTIC REAGENTS, INC.

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

Pre-market Notification Details

Device IDK945725
510k NumberK945725
Device Name:PHENYTION EIA TEST
ClassificationEnzyme Immunoassay, Diphenylhydantoin
Applicant DIAGNOSTIC REAGENTS, INC. 110 PIONEER WAY Mountain View,  CA  94041
ContactYuh-gen Tsay
CorrespondentYuh-gen Tsay
DIAGNOSTIC REAGENTS, INC. 110 PIONEER WAY Mountain View,  CA  94041
Product CodeDIP  
CFR Regulation Number862.3350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-11-22
Decision Date1995-02-03

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00380740135515 K945725 000
00380740102708 K945725 000

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