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Koagulab 60-S Coagulation System

by Ortho Diagnostic Systems, Inc. 510(k)

Active United States

510(k) K901120

Overview

The Koagulab 60-S Coagulation System is an automated coagulation instrument designed for clinical laboratories and hospital hematology departments. It is intended for the analysis of blood coagulation parameters in diagnostic testing.

The device is supplied as a single-use instrument and is not reusable. It operates within a clinical laboratory setting and is subject to regulatory oversight under FDA 510(k) clearance. Proper storage and handling are required to maintain device integrity.

AI-generated from registry data, 25 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 NumberK901120 Date22 May 1990ClearedStatusActive

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
GKP
Device Class
Class II
Regulation
21 CFR Part 864.5400
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Koagulab 60-S Coagulation System used for?

    The Koagulab 60-S is an automated coagulation instrument designed for clinical laboratories and hospital hematology departments to analyze blood coagulation parameters in diagnostic testing.

  • Is the Koagulab 60-S reusable?

    No, the device is supplied as a single-use instrument and is not reusable.

  • How is the Koagulab 60-S supplied?

    The device is supplied as a single-use instrument and is intended for use within a clinical laboratory setting.

  • What is the regulatory status of the Koagulab 60-S?

    The Koagulab 60-S Coagulation System is subject to regulatory oversight under FDA 510(k) clearance.