Skip to content

Aia-Pack Folate Assay

by Tosoh Medics, Inc. 2 variants

510(k) K992365

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 NumberK992365 Date10 Aug 1999ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-0672-2019 FDA Class II initiated 30 Nov 2018
    • Terminated Z-0082-2007 FDA Unclassified (pre-2012) initiated 1 Sep 2006 on shared 510(k) K992365

    Reports of low calibration rate value flags; Use of the recalled product may result in failure to calibrate the instrument

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
CGN
Device Class
Class II
Regulation
21 CFR Part 862.1295
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Other devices from Tosoh Medics, Inc.

See all devices from Tosoh Medics, Inc. →