ACTIVE ANDROSTENEDIONE EIA

Radioimmunoassay, Androstenedione

DIAGNOSTIC SYSTEMS LABORATORIES, INC.

The following data is part of a premarket notification filed by Diagnostic Systems Laboratories, Inc. with the FDA for Active Androstenedione Eia.

Pre-market Notification Details

Device IDK963002
510k NumberK963002
Device Name:ACTIVE ANDROSTENEDIONE EIA
ClassificationRadioimmunoassay, Androstenedione
Applicant DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster,  TX  77598
ContactJohn Willis
CorrespondentJohn Willis
DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster,  TX  77598
Product CodeCIZ  
CFR Regulation Number862.1075 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-08-02
Decision Date1996-08-16
Summary:summary

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