Cleared Traditional

T3 CLASP-BEAD EIA KIT

K893620 · Biotecx Laboratories, Inc. · Chemistry
Aug 1989
Decision
92d
Days
Class 2
Risk

About This 510(k) Submission

K893620 is an FDA 510(k) clearance for the T3 CLASP-BEAD EIA KIT, a Radioimmunoassay, Total Triiodothyronine (Class II — Special Controls, product code CDP), submitted by Biotecx Laboratories, Inc. (Friendswood, US). The FDA issued a Cleared decision on August 11, 1989, 92 days after receiving the submission on May 11, 1989. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1710.

Submission Details

510(k) Number K893620 FDA.gov
FDA Decision Cleared SESE
Date Received May 11, 1989
Decision Date August 11, 1989
Days to Decision 92 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

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

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