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Easy-Test Prothrombin Time PT Item No. 16628

by Em Diagnostic Systems, Inc. 510(k)

Active United States

510(k) K875062

Overview

The Easy-Test Prothrombin Time PT Item No. 16628 is a test for measuring prothrombin time (PT) to assess the extrinsic coagulation pathway in plasma samples. It is classified as a Test, Time, Prothrombin under product code GJS and is intended for use in hematology testing.

The device received FDA 510(k) clearance (K875062) on February 11, 1988, as substantially equivalent to a predicate device. It is a Class II medical device subject to special controls and was submitted by Em Diagnostic Systems, Inc. of Gibbstown, New Jersey.

AI-generated from registry data, 28 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK875062 Date11 Feb 1988ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

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

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Questions

  • What is the Easy-Test Prothrombin Time PT Item No. 16628 used for?

    It is used to measure prothrombin time (PT) in plasma samples to assess the extrinsic coagulation pathway, which helps evaluate blood clotting function in hematology testing.

  • How is the Easy-Test Prothrombin Time PT Item No. 16628 supplied?

    The device data does not specify the supply format, such as kit components, reagent stability, or packaging details, so this information cannot be determined from the provided data.

  • Is the Easy-Test Prothrombin Time PT Item No. 16628 sterile or single-use?

    The device data does not mention sterility, single-use designation, or reuse instructions, so these details are not available from the provided information.

  • What regulatory pathway was used for the Easy-Test Prothrombin Time PT Item No. 16628?

    It received FDA 510(k) clearance (K875062) on February 11, 1988, as substantially equivalent to a predicate device and is classified as a Class II medical device under product code GJS.