PHENYTOIN CALIBRATORS

Calibrators, Drug Specific

DIAGNOSTIC REAGENTS, INC.

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

Pre-market Notification Details

Device IDK945337
510k NumberK945337
Device Name:PHENYTOIN CALIBRATORS
ClassificationCalibrators, Drug Specific
Applicant DIAGNOSTIC REAGENTS, INC. 110 PIONEER WAY Mountain View,  CA  94041
ContactYug-gen Tsay
CorrespondentYug-gen Tsay
DIAGNOSTIC REAGENTS, INC. 110 PIONEER WAY Mountain View,  CA  94041
Product CodeDLJ  
CFR Regulation Number862.3200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-11-01
Decision Date1994-12-07

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