METHAQUALONE ENZYME IMMUNOASSAY

Radioimmunoassay, Methaqualone

DIAGNOSTIC REAGENTS, INC.

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

Pre-market Notification Details

Device IDK940123
510k NumberK940123
Device Name:METHAQUALONE ENZYME IMMUNOASSAY
ClassificationRadioimmunoassay, Methaqualone
Applicant DIAGNOSTIC REAGENTS, INC. 110 PIONEER WAY Mountain View,  CA  94041
ContactYuh-geng Tsaym Ph.d.
CorrespondentYuh-geng Tsaym Ph.d.
DIAGNOSTIC REAGENTS, INC. 110 PIONEER WAY Mountain View,  CA  94041
Product CodeKXS  
CFR Regulation Number862.3630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-01-10
Decision Date1994-05-03

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884883003415 K940123 000
00884883002937 K940123 000

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