ACTIVE DEHYDROEPIANDROSTERONE (DHEA)(DSL 9000)

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 Dehydroepiandrosterone (dhea)(dsl 9000).

Pre-market Notification Details

Device IDK935014
510k NumberK935014
Device Name:ACTIVE DEHYDROEPIANDROSTERONE (DHEA)(DSL 9000)
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 Received1993-10-20
Decision Date1994-05-09

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