DSL ACTIVE SHBG (DSL 7400)

Radioimmunoassay, Testosterones And Dihydrotestosterone

DIAGNOSTIC SYSTEMS LABORATORIES, INC.

The following data is part of a premarket notification filed by Diagnostic Systems Laboratories, Inc. with the FDA for Dsl Active Shbg (dsl 7400).

Pre-market Notification Details

Device IDK915823
510k NumberK915823
Device Name:DSL ACTIVE SHBG (DSL 7400)
ClassificationRadioimmunoassay, Testosterones And Dihydrotestosterone
Applicant DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster,  TX  77598
ContactJohnny R Willis
CorrespondentJohnny R Willis
DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster,  TX  77598
Product CodeCDZ  
CFR Regulation Number862.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-12-30
Decision Date1992-03-17

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