Cleared Traditional

ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG

K191533 · Siemens Healthcare Diagnostics, Inc. · Chemistry
Aug 2019
Decision
79d
Days
Class 1
Risk

About This 510(k) Submission

K191533 is an FDA 510(k) clearance for the ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG, a Radioimmunoassay, Testosterones And Dihydrotestosterone (Class I — General Controls, product code CDZ), submitted by Siemens Healthcare Diagnostics, Inc. (New York, US). The FDA issued a Cleared decision on August 28, 2019, 79 days after receiving the submission on June 10, 2019. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1680.

Submission Details

510(k) Number K191533 FDA.gov
FDA Decision Cleared SESE
Date Received June 10, 2019
Decision Date August 28, 2019
Days to Decision 79 days
Submission Type Traditional
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