Cleared Traditional

Elecsys FT4 III

K181233 · Roche Diagnostics · Chemistry
Sep 2018
Decision
132d
Days
Class 2
Risk

About This 510(k) Submission

K181233 is an FDA 510(k) clearance for the Elecsys FT4 III, a Radioimmunoassay, Free Thyroxine (Class II — Special Controls, product code CEC), submitted by Roche Diagnostics (Indianapolos, US). The FDA issued a Cleared decision on September 18, 2018, 132 days after receiving the submission on May 9, 2018. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1695.

Submission Details

510(k) Number K181233 FDA.gov
FDA Decision Cleared SESE
Date Received May 09, 2018
Decision Date September 18, 2018
Days to Decision 132 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