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Ventana Er Primary Antibody (Clone 6F11)

by Ventana, Inc.

510(k) K984567

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 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK984567 Date12 Aug 1999ClearedStatusActive

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-2716-2011 FDA Unclassified (pre-2012) initiated 16 May 2011
    • Terminated Z-2717-2011 FDA Unclassified (pre-2012) initiated 16 May 2011

    The recall was initiated because Ventana Medical Systems, Inc. (Ventana), has identified the presence of precipitate in some DAB chromogen dispensers in two lots of ultraView Universal DAB Detection Kit (part number 760-500, lot A05885 and lot B00988) and one lot of iView DAB Detection Kit (part number 760-091, lot B01057A.)

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  • Withdrawn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
MYA
Device Class
Class II
Regulation
21 CFR Part 864.1860
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent