Cleared Traditional

MICROZYME T3 ENZYME IMMUNOASSAY KIT

K904820 · Immunotech Corp. · Immunology
Dec 1990
Decision
55d
Days
Class 2
Risk

About This 510(k) Submission

K904820 is an FDA 510(k) clearance for the MICROZYME T3 ENZYME IMMUNOASSAY KIT, a Radioimmunoassay, Total Triiodothyronine (Class II — Special Controls, product code CDP), submitted by Immunotech Corp. (Boston, US). The FDA issued a Cleared decision on December 18, 1990, 55 days after receiving the submission on October 24, 1990. This device falls under the Immunology review panel. Regulated under 21 CFR 862.1710.

Submission Details

510(k) Number K904820 FDA.gov
FDA Decision Cleared SESE
Date Received October 24, 1990
Decision Date December 18, 1990
Days to Decision 55 days
Submission Type Traditional
Review Panel Immunology (IM)
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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