Apparatus, Automated Blood Cell Diluting

FDA product code GKH · Class I (low risk) · 21 CFR 864.5240 · Hematology

14510(k) clearances
0PMA approvals
2recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K100684Celltracks Autoprep System MODEL:9541GKH · Traditional Veridex, LLC08/26/2010SE
K040077Immunicon Celltracks Autoprep SystemGKH · Traditional Immunicon Corp.03/12/2004SE
K022512Cellprep Sample Preparation System, Model 9518GKH · Traditional Immunicon Corp.09/30/2002SE
K021150Coulter CellprepGKH · Traditional Beckman Coulter, Inc.06/11/2002SE
K935953Coulter Multi Q PrepGKH · Traditional Coulter Corp.03/11/1994SE
K923530Coulter Multi-Q-PrepGKH · Traditional Coulter Electronics, Inc.10/14/1992SE
K904795Facsprep Robotic Sample Preparation SystemGKH · Traditional Bd Becton Dickinson Vacutainer Systems Preanalytic12/31/1990SE
K882767Sysmex DD-100 Whole Blood Dilution SystemGKH · Traditional Toa Medical Electronics USA, Inc.07/18/1988SE
K852373AD150, Automated Hematology DilutorGKH · Traditional Abbott Diagnostics07/05/1985SE
K842747Hycel Dilutor, Various Models/MultiGKH · Traditional R&D Systems, Inc.10/01/1984SE
K842446Dilu-Matic 140GKH · Traditional Abbott Diagnostics09/06/1984SE
K823522Dilulab 230GKH · Traditional Innovative Medical Systems, Inc.12/28/1982SE
K791644Royco Model 371 Super DilutorGKH · Traditional Royco Instruments09/19/1979SE
K761137Microsample Blood Collection DeviceGKH · Traditional Ortho Diagnostics, Inc.02/07/1977SE

Recalls

RecallProductFirmInitiated
Z-2175-2010 CellTracks Auto Prep System, Circulating Tumor Cell Kit (epithelial, IVD Veridex, LLC a…Complaints of patient sample carryover. Veridex, LLC05/19/2010Terminated
Z-1734-2009 CellTracks AutoPrep System for in vitro diagnostic use, software version 2.2 or greater.…Bottle degradation: Investigation has determined that degradation may occur in the plastic waste bottle of… Veridex, LLC05/06/2009Terminated