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Staphylococcus Quickfish Bc

by Advandx, Inc.

510(k) K113371

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 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK113371 Date3 Apr 2012ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2138-2014 FDA Class II initiated 4 Jul 2014

    Positive result in the Internal negative control well for the Staphylococcus QuickFISH BC test, failing QC

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  • Withdrawn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
NXX
Device Class
Class I
Regulation
21 CFR Part 866.3700
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

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