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Flu Oia a/B Test Kit

by Thermo Biostar, Inc.

510(k) K023556

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 NumberK023556 Date27 Mar 2003ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0212-2009 FDA Unclassified (pre-2012) initiated 2 Jul 2008 on shared 510(k) K023556

    Diagnostic kits for flu were distributed with incorrect components.

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  • Withdrawn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
PSZ
Device Class
Class II
Regulation
21 CFR Part 866.3328
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

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