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Avandx E. Faecalis/Oe Pna Fish Culture Identification Kit

by Advandx, Inc.

510(k) K083074

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 10 Oct 2026. What this means

Regulatory status

as of registry sync 10 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK083074 Date24 Jul 2009ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2315-2010 FDA Unclassified (pre-2012) initiated 8 Jun 2010

    Some strains of streptococus anginosus cross-reach with E. faecalis/OE PNA FISH to produce a false positive green signal.

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  • Withdrawn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
OAH
Device Class
Class I
Regulation
21 CFR Part 866.3740
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

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