PHENOBARBITAL 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 Phenobarbital Calibrators.

Pre-market Notification Details

Device IDK945316
510k NumberK945316
Device Name:PHENOBARBITAL CALIBRATORS
ClassificationCalibrators, Drug Specific
Applicant DIAGNOSTIC REAGENTS, INC. 110 PIONEER WAY Mountain View,  CA  94041
ContactT Say
CorrespondentT Say
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 Date1995-01-04

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