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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.
 
DeviceColoHealth
Generic NameSystem, colorectal neoplasia, DNA methylation and hemoglobin detection
ApplicantNew Day Diagnostics, LLC
6701 Baum Dr.
Suite 110
Knoxville, TN 37919
PMA NumberP130001
Supplement NumberS009
Date Received10/01/2024
Decision Date03/19/2025
Product Code PHP 
Advisory Committee Pathology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the rebranding of the medical device previously known as Epi proColon® to ColoHealth™.
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