Cleared Traditional

MICROZYME(TM) FREE T4 ENZYME IMMUNOASSAY TEST

K911634 · Immunotech Corp. · Chemistry
Jun 1991
Decision
74d
Days
Class 2
Risk

About This 510(k) Submission

K911634 is an FDA 510(k) clearance for the MICROZYME(TM) FREE T4 ENZYME IMMUNOASSAY TEST, a Radioimmunoassay, Free Thyroxine (Class II — Special Controls, product code CEC), submitted by Immunotech Corp. (Boston, US). The FDA issued a Cleared decision on June 24, 1991, 74 days after receiving the submission on April 11, 1991. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1695.

Submission Details

510(k) Number K911634 FDA.gov
FDA Decision Cleared SESE
Date Received April 11, 1991
Decision Date June 24, 1991
Days to Decision 74 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CEC — Radioimmunoassay, Free Thyroxine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1695