CANNABINOID URINE CONTROLS

Drug Specific Control Materials

DIAGNOSTIC REAGENTS, INC.

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

Pre-market Notification Details

Device IDK921141
510k NumberK921141
Device Name:CANNABINOID URINE CONTROLS
ClassificationDrug Specific Control Materials
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 CodeLAS  
CFR Regulation Number862.3280 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-03-10
Decision Date1992-04-17

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