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Avl Omni Analyzer

by Avl Scientific Corp. 510(k)

Active United States

510(k) K954018

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK954018 Date5 Oct 1995ClearedStatusActive

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

8 recalls · FDA

  • 8 recalls, same reason

    • Terminated Z-0334-04 FDA Unclassified (pre-2012) initiated 29 Dec 2003 via K954018, on the same 510(k)
    • Terminated Z-0330-04 FDA Unclassified (pre-2012) initiated 29 Dec 2003 via K954018, on the same 510(k)
    • Terminated Z-0333-04 FDA Unclassified (pre-2012) initiated 29 Dec 2003 via K954018, on the same 510(k)
    • Terminated Z-0332-04 FDA Unclassified (pre-2012) initiated 29 Dec 2003 via K954018, on the same 510(k)
    • Terminated Z-0335-04 FDA Unclassified (pre-2012) initiated 29 Dec 2003 via K954018, on the same 510(k)
    • Terminated Z-0331-04 FDA Unclassified (pre-2012) initiated 29 Dec 2003 via K954018, on the same 510(k)
    • Terminated Z-0337-04 FDA Unclassified (pre-2012) initiated 29 Dec 2003 via K954018, on the same 510(k)
    • Terminated Z-0336-04 FDA Unclassified (pre-2012) initiated 29 Dec 2003 via K954018, on the same 510(k)

    The firm is withdrawing claims that pleural, pericardial, ascitic and cerebrospinal fluids are appropriate sample types for use on these instruments.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

Specification

510(k)

510(k) Number
FDA Product Code
GKR
Device Class
Class II
Regulation
21 CFR Part 864.5620
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

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