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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Immunomagnetic, Circulating Cancer Cell, Enumeration
510(k) Number K103502
Device Name CELLSEARCH CIRCULATING TUMOR CELL KIT MODEL 7900001
Applicant
VERIDEX, LLC
1001 US HIGHWAY 202 NORTH
RARITAN,  NJ  08869 -0606
Applicant Contact SARAH MCMANUS
Correspondent
VERIDEX, LLC
1001 US HIGHWAY 202 NORTH
RARITAN,  NJ  08869 -0606
Correspondent Contact SARAH MCMANUS
Regulation Number866.6020
Classification Product Code
NQI  
Date Received11/29/2010
Decision Date 12/21/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Pathology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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