Coatest Antithrombin

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K812829 ↗

FDA Product Code

JBQ

Device Class

Class II

Regulation

21 CFR Part 864.7060

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Coatest Plasminogen

  Class I

  FDA 510(k) K854572 Active Cleared 26 Feb 1986

• Coatest Heparin

  Class II

  FDA 510(k) K833891 Active Cleared 30 Jan 1984

• The I.V. Bag

  Class II

  FDA 510(k) K844664 Active Cleared 6 May 1985

• Coatest Factor VIII

  Class II

  FDA 510(k) K833892 Active Cleared 30 Jan 1984

• Coatest Antiplasmin

  Class II

  FDA 510(k) K833890 Active Cleared 30 Jan 1984

• Coatest Factor X

  Class II

  FDA 510(k) K832114 Active Cleared 26 Aug 1983

See all devices from Kabivitrum, Inc. →

• What is the Coatest Antithrombin used for?

  The Coatest Antithrombin is used for the quantitation of Antithrombin III in the field of Hematology.

• Is the Coatest Antithrombin a single-use device?

  The device description does not specify if it is single-use or reusable, but it is classified as a class 2 device.

• What regulatory clearance does the Coatest Antithrombin have?

  The Coatest Antithrombin has been granted FDA 510(k) clearance with the k number K812829.

• What is the product code for the Coatest Antithrombin?

  The product code for the Coatest Antithrombin is JBQ, and it is regulated under this code.