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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 K050245
Device Name CELLSEARCH CIRCULATING TUMOR CELL KIT
Applicant
Veridex, LLC
1001 U.S. Highway 202 N.
Raritan,  NJ  08869 -0606
Applicant Contact DEBRA J RASMUSSEN
Correspondent
Veridex, LLC
1001 U.S. Highway 202 N.
Raritan,  NJ  08869 -0606
Correspondent Contact DEBRA J RASMUSSEN
Regulation Number866.6020
Classification Product Code
NQI  
Date Received02/02/2005
Decision Date 03/15/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Pathology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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