URINE CALIBRATOR AND CONTROL

Calibrators, Drug Specific

DIAGNOSTIC REAGENTS, INC.

The following data is part of a premarket notification filed by Diagnostic Reagents, Inc. with the FDA for Urine Calibrator And Control.

Pre-market Notification Details

Device IDK931506
510k NumberK931506
Device Name:URINE CALIBRATOR AND CONTROL
ClassificationCalibrators, Drug Specific
Applicant DIAGNOSTIC REAGENTS, INC. 110 PIONEER WAY Mountain View,  CA  94041
ContactYuh-geng Tsay
CorrespondentYuh-geng 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 Received1993-03-25
Decision Date1993-07-28

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