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Panels › Hematology › Product code GKH · Class 1

Apparatus, Automated Blood Cell Diluting

Regulation 864.5240

0510(k)s in 12 months (14 all time)

0recalls in 12 months (2 all time)

2recalls that name a 510(k)

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Top companies in GKH

Company	510(k)s	Recalls
Veridex, LLC	1	2
Abbott Diagnostics	2	0
Immunicon Corp.	2	0
Bd Becton Dickinson Vacutainer Systems Preanalytic	1	0
Beckman Coulter, Inc.	1	0
Coulter Corp.	1	0
Coulter Electronics, Inc.	1	0
Innovative Medical Systems, Inc.	1	0
Ortho Diagnostics, Inc.	1	0
R&D Systems, Inc.	1	0

Date	Firm and product	Code	Linked 510(k)
Aug 5, 2010	Veridex, LLC CellTracks Auto Prep System, Circulating Tumor Cell Kit (epithelial, IVD Veridex, LLC a Johnson & Johnson Company Intended for the enumeration of circulating tumor cells (CTC) of epithelial origin in Terminated	GKH	K040077
Aug 13, 2009	Veridex, LLC CellTracks AutoPrep System for in vitro diagnostic use, software version 2.2 or greater. Distributed by Veridex, 33 Technology Drive, Warren, NJ 07059. Manufactured by Immunicon, Huntingdon Valley, Terminated	GKH	K040077

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