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Bd Geneohm Mrsa Acp Assay

by Bd Diagnostics (Geneohm Sciences, Inc.)

510(k) K093346

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 9 Oct 2026. What this means

Regulatory status

as of registry sync 9 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK093346 Date15 Dec 2009ClearedStatusActive

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-2317-2012 FDA Class II initiated 22 May 2012
    • Terminated Z-2316-2012 FDA Class II initiated 22 May 2012 on shared 510(k) K093346

    Leakage in Cepheid SmartCycler reaction tubes.

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  • Withdrawn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
NQX
Device Class
Class II
Regulation
21 CFR Part 866.1640
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

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