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Aia-Pack Tpoab Assay

by Tosoh Medics, Inc.

510(k) K981521

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 NumberK981521 Date8 Oct 1998ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-2827-2018 FDA Class III initiated 5 Jun 2018 on shared 510(k) K981521

    Distribution of unapproved product labeling

    • Terminated Z-2168-2017 FDA Class III initiated 8 Feb 2017

    The label contains two different methodologies. Quality Control values for non-FDA approved methodology (CL) are on the label in addition to the FDA approved methodology values (AIA). Two sets of instructions were included on the label.

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  • Withdrawn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
JZO
Device Class
Class II
Regulation
21 CFR Part 866.5870
Advisory Committee
Immunology
FDA Decision
SESE Substantially Equivalent

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