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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceEpi proColon
Generic NameSystem, colorectal neoplasia, DNA methylation and hemoglobin detection
ApplicantNew Day Diagnostics, LLC
6701 Baum Dr. Suite 110
Knoxville, TN 37919
PMA NumberP130001
Supplement NumberS002
Date Received05/10/2016
Decision Date10/18/2016
Product Code PHP 
Advisory Committee Pathology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol - OSB
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval of the post-approval study protocol.
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