Coatest Antiplasmin

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

510(k) Number

K833890 ↗

FDA Product Code

LGP

Device Class

Class II

Regulation

21 CFR Part 864.5425

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 Antithrombin

  Class II

  FDA 510(k) K812829 Active Cleared 30 Dec 1981

• Coatest Factor X

  Class II

  FDA 510(k) K832114 Active Cleared 26 Aug 1983

See all devices from Kabivitrum, Inc. →

• What is the primary clinical use of the Coatest Antiplasmin assay?

  The Coatest Antiplasmin assay is designed for use in hematology settings to measure the levels of antiplasmin present in a patient's blood sample.

• What is the regulatory status of this device?

  Coatest Antiplasmin is a Class 2 medical device that received FDA 510(k) clearance on January 30, 1984, under reference number K833890, having been determined to be substantially equivalent to existing devices.

• Under which regulation is this assay classified?

  This device is classified under regulation number 864.5425, which pertains to the Alpha-2-Antiplasmin assay used for diagnostic purposes within the field of hematology.