DHEA-SULFATE I RIA KIT

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 Dhea-sulfate I Ria Kit.

Pre-market Notification Details

Device IDK832154
510k NumberK832154
Device Name:DHEA-SULFATE I RIA KIT
ClassificationRadioimmunoassay, Dehydroepiandrosterone (free And Sulfate)
Applicant DIAGNOSTIC SYSTEMS LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeJKC  
CFR Regulation Number862.1245 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-07-05
Decision Date1983-08-16

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