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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 K113181
Model 9555
Device Name CELLTRACKS ANALYER II
Original Applicant
VERIDEX, LLC
1001 us highway 202 north
raritan,  NJ  08869 0606
Original Contact patricia hojnoski
Regulation Number866.6020
Classification Product Code
NQI  
Date Received10/28/2011
Decision Date 12/12/2011
Decision substantially equivalent (SE)
Classification Advisory Committee Pathology
Review Advisory Committee Immunology
summary summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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