Cleared Special

LIAISON Testosterone xt

K201908 · DiaSorin, Inc. · Chemistry
Oct 2020
Decision
98d
Days
Class 1
Risk

About This 510(k) Submission

K201908 is an FDA 510(k) clearance for the LIAISON Testosterone xt, a Radioimmunoassay, Testosterones And Dihydrotestosterone (Class I — General Controls, product code CDZ), submitted by DiaSorin, Inc. (Stillwater, US). The FDA issued a Cleared decision on October 15, 2020, 98 days after receiving the submission on July 9, 2020. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1680.

Submission Details

510(k) Number K201908 FDA.gov
FDA Decision Cleared SESE
Date Received July 09, 2020
Decision Date October 15, 2020
Days to Decision 98 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CDZ — Radioimmunoassay, Testosterones And Dihydrotestosterone
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1680

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