Cleared Traditional

T4 CLASP-BEAD EIA KIT

K892853 · Biotecx Laboratories, Inc. · Chemistry
May 1989
Decision
34d
Days
Class 2
Risk

About This 510(k) Submission

K892853 is an FDA 510(k) clearance for the T4 CLASP-BEAD EIA KIT, a Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine (Class II — Special Controls, product code KLI), submitted by Biotecx Laboratories, Inc. (Friendswood, US). The FDA issued a Cleared decision on May 22, 1989, 34 days after receiving the submission on April 18, 1989. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1700.

Submission Details

510(k) Number K892853 FDA.gov
FDA Decision Cleared SESE
Date Received April 18, 1989
Decision Date May 22, 1989
Days to Decision 34 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code KLI — Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1700

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