Cleared Traditional

FREE T4 (THYTOXINE) MICROPLATE EIA TEST MODELS # 1225-300

K020548 · Monobind · Chemistry
Apr 2002
Decision
45d
Days
Class 2
Risk

About This 510(k) Submission

K020548 is an FDA 510(k) clearance for the FREE T4 (THYTOXINE) MICROPLATE EIA TEST MODELS # 1225-300, a Radioimmunoassay, Free Thyroxine (Class II — Special Controls, product code CEC), submitted by Monobind (Costa Mesa, US). The FDA issued a Cleared decision on April 5, 2002, 45 days after receiving the submission on February 19, 2002. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1695.

Submission Details

510(k) Number K020548 FDA.gov
FDA Decision Cleared SESE
Date Received February 19, 2002
Decision Date April 05, 2002
Days to Decision 45 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

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