DSL ANDROSTANEDIOL GLUCURONIDE (DSL #6000)

Radioimmunoassay, Dehydroepiandrosterone (free And Sulfate)

DIAGNOSTIC SYSTEMS LABORATORIES, INC.

The following data is part of a premarket notification filed by Diagnostic Systems Laboratories, Inc. with the FDA for Dsl Androstanediol Glucuronide (dsl #6000).

Pre-market Notification Details

Device IDK903616
510k NumberK903616
Device Name:DSL ANDROSTANEDIOL GLUCURONIDE (DSL #6000)
ClassificationRadioimmunoassay, Dehydroepiandrosterone (free And Sulfate)
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 CodeJKC  
CFR Regulation Number862.1245 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-08-08
Decision Date1990-09-10

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