ACTIVE DEHYDROEPIANDROSTERONE (DHEA)(DSL 9000)— 510(k) K935014

Name: FDA 510(k) clearance K935014
Creator: U.S. Food and Drug Administration
Published: 1994-05-09

Substantially Equivalent

Diagnostic Systems Laboratories, Inc.

FDA 510(k) clearance K935014 for ACTIVE DEHYDROEPIANDROSTERONE (DHEA)(DSL 9000), Substantially Equivalent on 1994-05-09. Applicant: Diagnostic Systems Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Diagnostic Systems Laboratories, Inc.
Product code: Code JKC
Device class: Class 1
Regulation: 21 CFR 862.1245
Advisory panel: Clinical Chemistry
Date received: 1993-10-20
Decision date: 1994-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Webster, TX, US

Download summary PDF View on FDA.gov ↗

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