Cleared Traditional

T-3 MICROWELL EIA MODEL 7013

K960412 · Biomerica, Inc. · Chemistry
Mar 1996
Decision
50d
Days
Class 2
Risk

About This 510(k) Submission

K960412 is an FDA 510(k) clearance for the T-3 MICROWELL EIA MODEL 7013, a Radioimmunoassay, Total Triiodothyronine (Class II — Special Controls, product code CDP), submitted by Biomerica, Inc. (Newport Beach, US). The FDA issued a Cleared decision on March 19, 1996, 50 days after receiving the submission on January 29, 1996. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1710.

Submission Details

510(k) Number K960412 FDA.gov
FDA Decision Cleared SESE
Date Received January 29, 1996
Decision Date March 19, 1996
Days to Decision 50 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CDP — Radioimmunoassay, Total Triiodothyronine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1710

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