Cleared Traditional

MICROZYME T4 ENZYME IMMUNOASSAY KIT

K902922 · Immunotech Corp. · Chemistry
Jul 1990
Decision
24d
Days
Class 2
Risk

About This 510(k) Submission

K902922 is an FDA 510(k) clearance for the MICROZYME T4 ENZYME IMMUNOASSAY KIT, a Radioimmunoassay, Total Thyroxine (Class II — Special Controls, product code CDX), submitted by Immunotech Corp. (Boston, US). The FDA issued a Cleared decision on July 27, 1990, 24 days after receiving the submission on July 3, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1700.

Submission Details

510(k) Number K902922 FDA.gov
FDA Decision Cleared SESE
Date Received July 03, 1990
Decision Date July 27, 1990
Days to Decision 24 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

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

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