Cleared Special

ACTIVE? Free Testosterone RIA

K191350 · Immunotech S.R.O. · Chemistry

Dec 2019

Decision

214d

Days

Class 1

Risk

About This 510(k) Submission

K191350 is an FDA 510(k) clearance for the ACTIVE? Free Testosterone RIA, a Radioimmunoassay, Testosterones And Dihydrotestosterone (Class I — General Controls, product code CDZ), submitted by Immunotech S.R.O. (Prague, CZ). The FDA issued a Cleared decision on December 20, 2019, 214 days after receiving the submission on May 20, 2019. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1680.

Submission Details

510(k) Number	K191350 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 20, 2019
Decision Date	December 20, 2019
Days to Decision	214 days
Submission Type	Special
Review Panel	Chemistry (CH)
Summary	Summary PDF