Cleared Traditional

ARCHITECT SHBG

K152185 · Biokit, S.A. · Chemistry
Feb 2016
Decision
190d
Days
Class 1
Risk

About This 510(k) Submission

K152185 is an FDA 510(k) clearance for the ARCHITECT SHBG, a Radioimmunoassay, Testosterones And Dihydrotestosterone (Class I — General Controls, product code CDZ), submitted by Biokit, S.A. (Lli?a D'Amunt, ES). The FDA issued a Cleared decision on February 11, 2016, 190 days after receiving the submission on August 5, 2015. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1680.

Submission Details

510(k) Number K152185 FDA.gov
FDA Decision Cleared SESE
Date Received August 05, 2015
Decision Date February 11, 2016
Days to Decision 190 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