SRI TESTOSTERONE ENZYME IMMUNOASSAY— 510(k) K915164

Name: FDA 510(k) clearance K915164
Creator: U.S. Food and Drug Administration
Published: 1992-03-02

Substantially Equivalent

Serono-Baker Diagnostics, Inc.

FDA 510(k) clearance K915164 for SRI TESTOSTERONE ENZYME IMMUNOASSAY, Substantially Equivalent on 1992-03-02. Applicant: Serono-Baker Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Serono-Baker Diagnostics, Inc.
Product code: Code CDZ
Device class: Class 1
Regulation: 21 CFR 862.1680
Advisory panel: Clinical Chemistry
Date received: 1991-11-14
Decision date: 1992-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Allentown, PA, 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.