Cleared Traditional

OPTICOAT T3 EIA KIT

K981824 · Biotecx Laboratories, Inc. · Chemistry
Dec 1998
Decision
214d
Days
Class 2
Risk

About This 510(k) Submission

K981824 is an FDA 510(k) clearance for the OPTICOAT T3 EIA KIT, a Radioimmunoassay, Total Triiodothyronine (Class II — Special Controls, product code CDP), submitted by Biotecx Laboratories, Inc. (Houston, US). The FDA issued a Cleared decision on December 22, 1998, 214 days after receiving the submission on May 22, 1998. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1710.

Submission Details

510(k) Number K981824 FDA.gov
FDA Decision Cleared SESE
Date Received May 22, 1998
Decision Date December 22, 1998
Days to Decision 214 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

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

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