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Excell 22

by Mwi, Inc.

510(k) K991539

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

4 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 · Traditional NumberK991539 Date1 Jul 1999ClearedStatusActive

Recalls

4 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0451-2007 FDA Unclassified (pre-2012) initiated 20 Sep 2006
    • Terminated Z-0450-2007 FDA Unclassified (pre-2012) initiated 20 Sep 2006

    System has given inaccurate readings when running samples that trigger an extra rinse due to very high WBC, RBC or Platlet counts.

  • 2 recalls, same reason

    • Terminated Z-0449-2007 FDA Unclassified (pre-2012) initiated 24 Aug 2006
    • Terminated Z-0448-2007 FDA Unclassified (pre-2012) initiated 24 Aug 2006

    Flags and alerts on the user interface will not automatically transfering to the LIS.

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  • Withdrawn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