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Modification to Coulter Lh 750 Hematology Analyzer, Model 6605632

by Beckman Coulter, Inc.

510(k) K022161

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

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 · Special NumberK022161 Date29 Jul 2002ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-3113-2017 FDA Class II initiated 26 Jun 2017

    Beckman Coulter has determined that additional clarification for the Blast Suspect messages is necessary. In rare situations, the LH 750, LH 780, LH 500 and HmX Analyzers may not flag or detect blasts in some blood samples.

    • Terminated Z-0415-03 FDA Unclassified (pre-2012) initiated 8 Nov 2002

    Software vote out logic changed. Erroneous white blood cell counts.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

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

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