Autostat II Anti-TPO

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K943580 ↗

FDA Product Code

JNL

FDA applicant

Cogent Diagnotics , Ltd.

Device Class

Class II

Regulation

21 CFR Part 866.5870

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Autostat Antithyroglobin

  Class II

  FDA 510(k) K925784 Active Cleared 21 Jan 1993

• Autostat(Tm) Anti-Dsna

  Class II

  FDA 510(k) K913342 Active Cleared 1 May 1992

• Autostat Anti-Thyroglobulin

  Class II

  FDA 510(k) K923370 Active Cleared 22 Sep 1992

• Autostat II Anti-Ss-a/Ro Elisa

  Class II

  FDA 510(k) K990627 Active Cleared 28 Apr 1999

• Autostat II ANA Screen ELISA

  Class II

  FDA 510(k) K983655 Active Cleared 28 Jan 1999

• Autostat II Anti-Cardiolipin Screen Elisa

  Class II

  FDA 510(k) K993085 Active Cleared 1 Feb 2000

See all devices from Cogent Diagnotics, Ltd. →

• What is the primary function of the Autostat II Anti-TPO?

  The Autostat II Anti-TPO is an in vitro diagnostic tool designed specifically for the detection of thyroglobulin autoantibodies. It operates within the field of immunology to assist in clinical laboratory testing.

• What is the regulatory classification of this device?

  The Autostat II Anti-TPO is classified as a Class II medical device under regulation number 866.5870. It has received FDA 510(k) clearance, confirming it as substantially equivalent to other legally marketed devices.

• Who is the manufacturer of the Autostat II Anti-TPO?

  This device is manufactured by Cogent Diagnostics, Ltd., located in Edinburgh, United Kingdom. The company is the applicant responsible for the device's FDA 510(k) clearance under K943580.