Cleared Traditional

K904539 - FLAGEN TM FREE T4
(FDA 510(k) Clearance)

K904539 · Cyberfluor, Inc. · Chemistry

Nov 1990

Decision

57d

Days

Class 2

Risk

K904539 is an FDA 510(k) clearance for the FLAGEN TM FREE T4. This device is classified as a Radioimmunoassay, Free Thyroxine (Class II — Special Controls, product code CEC).

Submitted by Cyberfluor, Inc. (Ontario M5t 1x4, CA). The FDA issued a Cleared decision on November 30, 1990, 57 days after receiving the submission on October 4, 1990.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1695.

Submission Details

510(k) Number	K904539 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 04, 1990
Decision Date	November 30, 1990
Days to Decision	57 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—