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Celltracka Analyzer II

by Immunicon Corp.

510(k) K050145

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 NumberK050145 Date15 Mar 2005ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-1195-2014 FDA Class II initiated 8 Jan 2014

    Janssen Diagnostics, LLC received complaints of camera failures on the CELLTRACKS ANALYZER II.

    • Terminated Z-1004-2012 FDA Unclassified (pre-2012) initiated 17 Aug 2011

    Control cell images may i intermix with Patient cell images while changing between the Control review screen and Patient review screen on the Cell tracks Analyzer II.

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  • Withdrawn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
NQI
Device Class
Class II
Regulation
21 CFR Part 866.6020
Advisory Committee
Immunology
FDA Decision
SESE Substantially Equivalent

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