Cleared Traditional

THYROXINE (T4) COATED TUBE RIA

K921935 · Monobind · Chemistry
Jul 1992
Decision
74d
Days
Class 2
Risk

About This 510(k) Submission

K921935 is an FDA 510(k) clearance for the THYROXINE (T4) COATED TUBE RIA, a Radioimmunoassay, Total Thyroxine (Class II — Special Controls, product code CDX), submitted by Monobind (Costa Mesa, US). The FDA issued a Cleared decision on July 7, 1992, 74 days after receiving the submission on April 24, 1992. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1700.

Submission Details

510(k) Number K921935 FDA.gov
FDA Decision Cleared SESE
Date Received April 24, 1992
Decision Date July 07, 1992
Days to Decision 74 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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