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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Namesystem, colorectal neoplasia, dna methylation and hemoglobin detection
Generic Namesdna-based colorectal cancer screening test
PMA NumberP130017
Supplement NumberS004
Date Received07/27/2015
Decision Date09/25/2015
Product Code
PHP[ Registered Establishments with PHP ]
Advisory Committee Pathology
Supplement Typenormal 180 day track no user fee
Supplement Reason pas protocal supplement osb
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of the post-approval study protocol.