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Diastat Anti-Cardiolipin Iga, Model Fcar 500

by Axis-Shield, Ltd.

510(k) K001981

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 NumberK001981 Date21 Aug 2000ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-0927-05 FDA Unclassified (pre-2012) initiated 1 Nov 2004

    DiaSorin Anti-Cardiolipin IgA Kit, catalog no. 7800, positive control was on the low limit of the acceptable range (16-35 U/mL).

    • Terminated Z-0632-05 FDA Unclassified (pre-2012) initiated 23 Jan 2004

    DiaSorin Anti-Cardiolipin IgA kit's positive control is out of acceptable limits.

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  • Withdrawn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
FDA applicant
Axis-Shield , Ltd.
Device Class
Class II
Regulation
21 CFR Part 866.5660
Advisory Committee
Immunology
FDA Decision
SESE Substantially Equivalent

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