Cleared Traditional

T4 EIA BEAD ASSAY

K920766 · Tech-Co, Inc. · Chemistry
Apr 1992
Decision
58d
Days
Class 2
Risk

About This 510(k) Submission

K920766 is an FDA 510(k) clearance for the T4 EIA BEAD ASSAY, a Radioimmunoassay, Total Thyroxine (Class II — Special Controls, product code CDX), submitted by Tech-Co, Inc. (Rochester Hills, US). The FDA issued a Cleared decision on April 17, 1992, 58 days after receiving the submission on February 19, 1992. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1700.

Submission Details

510(k) Number K920766 FDA.gov
FDA Decision Cleared SESE
Date Received February 19, 1992
Decision Date April 17, 1992
Days to Decision 58 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code CDX — Radioimmunoassay, Total Thyroxine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1700

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