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Aeskulisa Ttg a and Aeskulisa Ttg G

by Aesku, Inc.

510(k) K042644

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 10 Oct 2026. What this means

Regulatory status

as of registry sync 10 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK042644 Date1 Jun 2005ClearedStatusActive

Recalls

1 recall · FDA

    • Completed Z-1800-2020 FDA Class II initiated 3 Apr 2019

    An elevated lot-to-lot bias was observed for Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA when compared to a previous lot of product. The observed elevated bias between these two lots is largely due to samples with higher levels of antibodies. With the cut-off for the assay being 15 U/mL, the clinical classifications for most samples would remain unchanged.

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  • Withdrawn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

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