DEHYDROEPIANDROSTERONE SULFATE KIT RIA— 510(k) K802195

Name: FDA 510(k) clearance K802195
Creator: U.S. Food and Drug Administration
Published: 1980-10-23

Substantially Equivalent

Radioassay Systems Laboratories, Inc.

FDA 510(k) clearance K802195 for DEHYDROEPIANDROSTERONE SULFATE KIT RIA, Substantially Equivalent on 1980-10-23. Applicant: Radioassay Systems Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Radioassay Systems Laboratories, Inc.
Product code: Code JKC
Device class: Class 1
Regulation: 21 CFR 862.1245
Advisory panel: Clinical Chemistry
Date received: 1980-09-10
Decision date: 1980-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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