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Aia-Pack FT3 Assay

by Tosoh Medics, Inc. 2 variants

510(k) K963687

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK963687 Date8 Nov 1996ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0673-2019 FDA Class II initiated 30 Nov 2018

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  • Withdrawn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
CDP
Device Class
Class II
Regulation
21 CFR Part 862.1710
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

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