Skip to content

CD-Chex + RBC

by Streck Laboratories, Inc.

510(k) K960894

Active European Union and United States

CE IVDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K960894↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK960894 Date24 May 1996ClearedStatusActive
European UnionCE/IVDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

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

Overview

AI-generated summary, 18 Sep 2026

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

The CD-Chex + RBC is a Control, White-Cell device classified under the Hematology specialty, designed for use in blood cell analysis. It serves as a reference standard for red blood cells (RBC) and white blood cells (WBC), providing a controlled sample for quality assurance and validation in hematological testing procedures.

This device is supplied as a single-use reagent and is intended for laboratory settings where precise hematological measurements are required. It is sterile and must be stored under controlled conditions as specified by the manufacturer. Authorized under FDA 510K and IVDR, the CD-Chex + RBC adheres to regulatory standards for hematology controls, ensuring reliability in diagnostic testing.

Other devices from Streck Laboratories, Inc.

See all devices from Streck Laboratories, Inc. →

Questions

AI-generated answers, 18 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 CD-Chex + RBC used for in a clinical laboratory setting?

    The CD-Chex + RBC is a reference standard specifically designed for quality assurance and validation in blood cell analysis within hematology laboratories. It provides a controlled sample of red blood cells (RBC) and white blood cells (WBC) to help ensure the accuracy and reliability of hematological testing equipment and procedures.

  • Is the CD-Chex + RBC intended for single-use or can it be reused?

    The CD-Chex + RBC is supplied as a single-use reagent, meaning each unit is intended for one-time use in laboratory testing. This design ensures consistency and sterility for accurate quality control measurements.

  • How should the CD-Chex + RBC be stored to maintain its integrity?

    The CD-Chex + RBC must be stored under controlled conditions as specified by the manufacturer to preserve its sterility and performance. While the exact storage instructions are not detailed here, typical single-use reagents like this require protection from extreme temperatures, light, and contamination.

  • What regulatory pathways has the CD-Chex + RBC followed for approval?

    The CD-Chex + RBC has been authorized through both the FDA’s 510(k) pathway (traditional clearance under K960894) and the In Vitro Diagnostic Regulation (IVDR) in the European Union. This ensures compliance with U.S. and EU standards for hematology controls.