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Immunicon Celltracks Autoprep System

by Immunicon Corp.

510(k) K040077

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 10 Oct 2026. What this means

Regulatory status

as of registry sync 10 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK040077 Date12 Mar 2004ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-2175-2010 FDA Unclassified (pre-2012) initiated 19 May 2010

    Complaints of patient sample carryover.

    • Terminated Z-1734-2009 FDA Unclassified (pre-2012) initiated 6 May 2009

    Bottle degradation: Investigation has determined that degradation may occur in the plastic waste bottle of the CellTracks AutoPrep System.

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  • Withdrawn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
GKH
Device Class
Class I
Regulation
21 CFR Part 864.5240
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

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