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QBC Centrifugal Hematology Control/Multiple

by R&D Systems, Inc. United States 510(k)

510(k) K904637 Product code JPK

Overview

The QBC Centrifugal Hematology Control/Multiple is a hematology quality control mixture used for calibration and quality assurance in hematology testing. It is designed to be used with centrifugal hematology analyzers to ensure accurate and reliable test results.

This control is supplied as a multiple-parameter control and is intended for single-use in laboratory settings. It is not MRI safe and should be stored according to the manufacturer's instructions. The device has FDA 510(k) clearance with product code JPK and is classified as a Class II medical device.

Summary written by AI from registry data, 21 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK904637 Date29 Oct 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: none on record (FDA, checked 22 Oct 2026)

Specification

510(k) · synced 22 Oct 2026

Full name
Qbc(R) Centrifugal Hematology Control/Multiple
510(k) Number
FDA Product Code
JPK
Device Class
Class II
Regulation
21 CFR Part 864.8625
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the QBC Centrifugal Hematology Control/Multiple used for?

    The QBC Centrifugal Hematology Control/Multiple is a hematology quality control mixture used for calibration and quality assurance in hematology testing. It is designed to be used with centrifugal hematology analyzers to ensure accurate and reliable test results.

  • How is the QBC Centrifugal Hematology Control/Multiple supplied?

    This control is supplied as a multiple-parameter control and is intended for single-use in laboratory settings. It should be stored according to the manufacturer's instructions and is not MRI safe.

  • What is the regulatory classification of the QBC Centrifugal Hematology Control/Multiple?

    The device has FDA 510(k) clearance with product code JPK and is classified as a Class II medical device. It is substantially equivalent to other hematology quality control mixtures.

  • Can the QBC Centrifugal Hematology Control/Multiple be reused?

    No, the QBC Centrifugal Hematology Control/Multiple is intended for single-use in laboratory settings only. It should not be reused or repurposed for any other applications.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K904637 24 fields · synced 22 Oct 2026