DSL 7900 ACTIVE DHEA-S (DSL #7900)

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 7900 Active Dhea-s (dsl #7900).

Pre-market Notification Details

Device IDK891478
510k NumberK891478
Device Name:DSL 7900 ACTIVE DHEA-S (DSL #7900)
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 Received1989-03-16
Decision Date1989-04-26

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