ACTIVE® Free Testosterone RIA— 510(k) K191350

Name: FDA 510(k) clearance K191350
Creator: U.S. Food and Drug Administration
Published: 2019-12-20

Substantially Equivalent

Immunotech S.R.O.

FDA 510(k) clearance K191350 for ACTIVE® Free Testosterone RIA, Substantially Equivalent on 2019-12-20. Applicant: Immunotech S.R.O.. Device class: 1.

Clearance details

Applicant: Immunotech S.R.O.
Product code: Code CDZ
Device class: Class 1
Regulation: 21 CFR 862.1680
Advisory panel: Clinical Chemistry
Date received: 2019-05-20
Decision date: 2019-12-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Prague, CZ

Download summary PDF View on FDA.gov ↗

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