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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 K130794
Device Name CELLTRACKS ANALYZER II SYSTEM
Applicant
Veridex, LLC
1001 U.S. Highway 202 N.
Raritan,  NJ  08869 -0606
Applicant Contact KIMBERLY PRESCOTT
Correspondent
Veridex, LLC
1001 U.S. Highway 202 N.
Raritan,  NJ  08869 -0606
Correspondent Contact KIMBERLY PRESCOTT
Regulation Number866.6020
Classification Product Code
NQI  
Date Received03/22/2013
Decision Date 06/20/2013
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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