ACTIVE DHEA-SULFATE DSL3500

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 Active Dhea-sulfate Dsl3500.

Pre-market Notification Details

Device IDK851239
510k NumberK851239
Device Name:ACTIVE DHEA-SULFATE DSL3500
ClassificationRadioimmunoassay, Dehydroepiandrosterone (free And Sulfate)
Applicant DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster,  TX  77598
ContactGopal Savjani
CorrespondentGopal Savjani
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 Received1985-03-27
Decision Date1985-04-25

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