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Ortho Assayed Reference Plasma-Normal/ Plasma-Abnormal

by Ortho Diagnostic Systems, Inc. 510(k)

Active United States

510(k) K940209

Overview

Ortho Assayed Reference Plasma-Normal/Plasma-Abnormal is a plasma coagulation control device used to monitor and verify the performance of coagulation assays. It is designed to provide reference values for normal and abnormal plasma samples, ensuring accuracy in diagnostic testing.

The device is supplied as a single-use plasma product and is intended for use in coagulation testing systems. It is not sterilized and should be stored according to manufacturer instructions. The device is regulated under FDA 510(k) clearance (K940209) and is classified as a Class II device with special controls.

AI-generated from registry data, 26 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 NumberK940209 Date11 May 1995ClearedStatusActive

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
GGN
Device Class
Class II
Regulation
21 CFR Part 864.5425
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the primary use of Ortho Assayed Reference Plasma-Normal/Abnormal?

    This device is a plasma coagulation control used to monitor and verify the performance of coagulation assays. It provides reference values for normal and abnormal plasma samples to ensure diagnostic testing accuracy.

  • How is the Ortho Assayed Reference Plasma supplied?

    The device is supplied as a single-use plasma product intended for use in coagulation testing systems.

  • Is the Ortho Assayed Reference Plasma sterile?

    No, the device is not sterilized and should be stored according to the manufacturer's instructions.

  • What is the regulatory status of this device?

    The device is regulated under FDA 510(k) clearance (K940209) and is classified as a Class II device with special controls.