Cleared Traditional

VIDAS FT4

K132058 · Biomerieux S.A. · Chemistry
Jun 2015
Decision
705d
Days
Class 2
Risk

About This 510(k) Submission

K132058 is an FDA 510(k) clearance for the VIDAS FT4, a Radioimmunoassay, Free Thyroxine (Class II — Special Controls, product code CEC), submitted by Biomerieux S.A. (Craponne, FR). The FDA issued a Cleared decision on June 8, 2015, 705 days after receiving the submission on July 3, 2013. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1695.

Submission Details

510(k) Number K132058 FDA.gov
FDA Decision Cleared SESE
Date Received July 03, 2013
Decision Date June 08, 2015
Days to Decision 705 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CEC — Radioimmunoassay, Free Thyroxine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1695