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Aia Nexia-Automated Enzyme Immunoassay System

by Tosoh Medics, Inc.

510(k) K971103

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 NumberK971103 Date27 Jun 1997ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-1830-2013 FDA Class II initiated 15 May 2013

    Visual inspection of the pipette tips indicated that some of the tips were not uniform in size/length which was causing error messages on the analyzers.

    • Terminated Z-0218-05 FDA Unclassified (pre-2012) initiated 2 Apr 2003 on shared 510(k) K971103

    A software upgrade was released by the firm for its AIA-600 II analyzers, in that washing deficiencies caused by the analyzer were corrected.

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  • Withdrawn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
KHO
Device Class
Class I
Regulation
21 CFR Part 862.2560
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

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