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Thromboplastin, for Use in Prothrombin Time Deter.

by Medical Diagnostic Technologies, Inc.

510(k) K896625

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 NumberK896625 Date11 Dec 1989ClearedStatusActive

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  • Withdrawn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
GJS
Device Class
Class II
Regulation
21 CFR Part 864.7750
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

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

Thromboplastin, for Use in Prothrombin Time Determination is a diagnostic reagent used in laboratory settings for the prothrombin time (PT) test. It is a naturally occurring protein that serves as an essential component in blood coagulation assays.

The device is supplied as a reagent for in vitro diagnostic use and is intended for use in clinical laboratories. It is regulated under FDA 510(k) clearance K896625, product code GJS, and regulation number 864.7750, with a device class of 2 and medical specialty in hematology.

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