Cleared Traditional

FREE T4 MICROWELL EIA, MODEL #7019

K982954 · Biomerica, Inc. · Chemistry
Sep 1998
Decision
31d
Days
Class 2
Risk

About This 510(k) Submission

K982954 is an FDA 510(k) clearance for the FREE T4 MICROWELL EIA, MODEL #7019, a Radioimmunoassay, Free Thyroxine (Class II — Special Controls, product code CEC), submitted by Biomerica, Inc. (Newport Beach, US). The FDA issued a Cleared decision on September 24, 1998, 31 days after receiving the submission on August 24, 1998. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1695.

Submission Details

510(k) Number K982954 FDA.gov
FDA Decision Cleared SESE
Date Received August 24, 1998
Decision Date September 24, 1998
Days to Decision 31 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