DHEA TEST SET— 510(k) K771793

Substantially Equivalent

Wien Laboratories, Inc.

FDA 510(k) clearance K771793 for DHEA TEST SET, Substantially Equivalent on 1977-11-02. Applicant: Wien Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Wien Laboratories, Inc.
Product code: Code CIY
Device class: Class 1
Regulation: 21 CFR 862.1080
Advisory panel: Clinical Chemistry
Date received: 1977-09-22
Decision date: 1977-11-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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