Cleared Traditional

Elecsys FT4 IV

K220456 · Roche Diagnostics · Chemistry
Apr 2023
Decision
414d
Days
Class 2
Risk

About This 510(k) Submission

K220456 is an FDA 510(k) clearance for the Elecsys FT4 IV, a Radioimmunoassay, Free Thyroxine (Class II — Special Controls, product code CEC), submitted by Roche Diagnostics (Indianapolos, US). The FDA issued a Cleared decision on April 7, 2023, 414 days after receiving the submission on February 17, 2022. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1695.

Submission Details

510(k) Number K220456 FDA.gov
FDA Decision Cleared SESE
Date Received February 17, 2022
Decision Date April 07, 2023
Days to Decision 414 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