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Diastat Anti-Cardiolipin Igg/Igm, Model Fcar 600

by Axis-Shield

510(k) K001574

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 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK001574 Date9 Jun 2000ClearedStatusActive

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-2920-2018 FDA Class III initiated 21 Oct 2016
    • Terminated Z-2921-2018 FDA Class III initiated 21 Oct 2016

    Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin.

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  • Withdrawn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
MID
Device Class
Class II
Regulation
21 CFR Part 866.5660
Advisory Committee
Immunology
FDA Decision
SESE Substantially Equivalent

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