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Gram-Negative Quickfish Bc

by Advandx, Inc.

510(k) K123418

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 NumberK123418 Date21 Jul 2013ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0619-2014 FDA Class III initiated 11 Dec 2013

    Kits incompatible with certain fluorescence microscope light sources

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  • Withdrawn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
JSS
Device Class
Class I
Regulation
21 CFR Part 866.2660
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

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