Skip to content

DXH 300 Coulter Cellular Analysis System, DXH 300C Coulter Cellular Analysis System Model: 71772, 71771

by Beckman Coulter Cellular

510(k) K100489

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK100489 Date26 Oct 2010ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

Full name
Dxh 300 Coulter Cellular Analysis System, Dxh 300C Coulter Cellular Analyssi System Model: 71772, 71771
510(k) Number
FDA Product Code
GKZ
Device Class
Class II
Regulation
21 CFR Part 864.5220
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

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

The DXH 300 Coulter Cellular Analysis System is a hematology device used for cellular analysis. It performs differential cell counting and analysis of blood samples.

The system is manufactured by Beckman Coulter Cellular and is supplied as a reusable device. It received FDA 510(k) clearance with K number K100489 on October 26, 2010, and is classified under product code GKZ.

Questions

AI-generated answers, 6 Oct 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 DXH 300 Coulter Cellular Analysis System used for?

    The DXH 300 Coulter Cellular Analysis System is a hematology device used for cellular analysis. It performs differential cell counting and analysis of blood samples to assist in clinical diagnostics.

  • Is the DXH 300 system a single-use or reusable device?

    The DXH 300 Coulter Cellular Analysis System is supplied as a reusable device. It is designed for multiple uses in clinical laboratory settings for blood sample analysis.

  • What regulatory approvals does the DXH 300 system have?

    The DXH 300 Coulter Cellular Analysis System received FDA 510(k) clearance with K number K100489 on October 26, 2010. It is classified under product code GKZ and is substantially equivalent to predicate devices.

  • What models of the DXH 300 system are available?

    The DXH 300 Coulter Cellular Analysis System is available in models 71772 and 71771. Both models perform the same differential cell counting and analysis functions for blood samples.