Turbox Antithrombin III

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K884144 ↗

FDA Product Code

JBQ

FDA applicant

Unipath , Ltd.

Device Class

Class II

Regulation

21 CFR Part 864.7060

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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See all devices from Unipath, Ltd. →

• What is the primary clinical use of the Turbox Antithrombin III?

  This device is intended for the quantitation of antithrombin III. It is categorized under the hematology medical specialty and is designed specifically for use within clinical laboratory environments to support diagnostic testing.

• How is the Turbox Antithrombin III regulated?

  The device is regulated under FDA 510(k) number K884144 and adheres to regulation number 864.7060. It is identified by product code JBQ and was determined to be substantially equivalent through the traditional 510(k) submission process.

• Who is the manufacturer of this device?

  The Turbox Antithrombin III is manufactured by Unipath, Ltd., located in Bedford, United Kingdom. The company manages the production and regulatory compliance for this specific hematology testing device.