Cleared Traditional

K895186 - FIAGEN T3 UPTAKE CATALOGUE #101-402
(FDA 510(k) Clearance)

K895186 · Cyberfluor, Inc. · Chemistry

Nov 1989

Decision

89d

Days

Class 2

Risk

K895186 is an FDA 510(k) clearance for the FIAGEN T3 UPTAKE CATALOGUE #101-402. This device is classified as a Radioassay, Triiodothyronine Uptake (Class II — Special Controls, product code KHQ).

Submitted by Cyberfluor, Inc. (Ontario M5t 1x4, CA). The FDA issued a Cleared decision on November 8, 1989, 89 days after receiving the submission on August 11, 1989.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1715.

Submission Details

510(k) Number	K895186 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 11, 1989
Decision Date	November 08, 1989
Days to Decision	89 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—