125 I-DEHYDROEPIANDROSTERONE SULFATE— 510(k) K823200

Name: FDA 510(k) clearance K823200
Creator: U.S. Food and Drug Administration
Published: 1982-11-29

Substantially Equivalent

Wien Laboratories, Inc.

FDA 510(k) clearance K823200 for 125 I-DEHYDROEPIANDROSTERONE SULFATE, Substantially Equivalent on 1982-11-29. Applicant: Wien Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Wien Laboratories, Inc.
Product code: Code JKC
Device class: Class 1
Regulation: 21 CFR 862.1245
Advisory panel: Clinical Chemistry
Date received: 1982-10-26
Decision date: 1982-11-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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