Cleared Traditional

K905656 - FLAGEN TRIIODOTHYRONINE (T3) ASSAY
(FDA 510(k) Clearance)

K905656 · Cyberfluor, Inc. · Chemistry

Jan 1991

Decision

37d

Days

Class 2

Risk

K905656 is an FDA 510(k) clearance for the FLAGEN TRIIODOTHYRONINE (T3) ASSAY. This device is classified as a Radioimmunoassay, Total Triiodothyronine (Class II — Special Controls, product code CDP).

Submitted by Cyberfluor, Inc. (Ontario M5t 1x4, CA). The FDA issued a Cleared decision on January 23, 1991, 37 days after receiving the submission on December 17, 1990.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1710.

Submission Details

510(k) Number	K905656 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 17, 1990
Decision Date	January 23, 1991
Days to Decision	37 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—