SHBG— 510(k) K912850

Substantially Equivalent

Wien Laboratories, Inc.

FDA 510(k) clearance K912850 for SHBG, Substantially Equivalent on 1991-08-12. Applicant: Wien Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Wien Laboratories, Inc.
Product code: Code CDZ
Device class: Class 1
Regulation: 21 CFR 862.1680
Advisory panel: Clinical Chemistry
Date received: 1991-06-28
Decision date: 1991-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Succasunna, NJ, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.