Cleared Traditional

K943580 - AUTOSTAT II ANTI-TPO
(FDA 510(k) Clearance)

K943580 · Cogent Diagnotics , Ltd. · Immunology

Apr 1995

Decision

269d

Days

Class 2

Risk

K943580 is an FDA 510(k) clearance for the AUTOSTAT II ANTI-TPO, a Immunochemical, Thyroglobulin Autoantibody (Class II — Special Controls, product code JNL), submitted by Cogent Diagnotics , Ltd. (Edinburgh, GB). The FDA issued a Cleared decision on April 17, 1995, 269 days after receiving the submission on July 22, 1994. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5870.

Submission Details

510(k) Number	K943580 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 22, 1994
Decision Date	April 17, 1995
Days to Decision	269 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Statement