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Ventana Anti-Helicobacter Pylori (SP48) Rabbit Monoclonal Primary Antibody

by Ventana Medical Systems, Inc.

510(k) K101234

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 NumberK101234 Date25 Aug 2011ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-3010-2018 FDA Class I initiated 2 Aug 2018

    Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.

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  • Withdrawn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
OWF
Device Class
Class I
Regulation
21 CFR Part 866.3110
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

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