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Thrombo-Test (X)

by Medtro GmbH

510(k) K801054

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK801054 Date13 Mar 1981ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
JPK
Device Class
Class II
Regulation
21 CFR Part 864.8625
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Thrombo-Test (X) is a hematology quality control mixture. It is classified as a class 2 medical device used within the field of hematology.

This device is regulated under 21 CFR 864.8625 and has received FDA 510(k) clearance under the number K801054. It is manufactured by Medtro GmbH.

Questions

AI-generated answers, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary purpose of the Thrombo-Test (X)?

    The Thrombo-Test (X) is designed to function as a hematology quality control mixture. It is used within clinical hematology settings to ensure the accuracy and reliability of diagnostic testing procedures.

  • What is the regulatory classification of this device?

    The Thrombo-Test (X) is classified as a class 2 medical device. It is regulated under 21 CFR 864.8625 and has received FDA 510(k) clearance under the submission number K801054.

  • Who is the manufacturer of the Thrombo-Test (X)?

    The Thrombo-Test (X) is manufactured by Medtro GmbH, which is located in Mchenry, Illinois.