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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.
 
DeviceColoSense
Generic NameSystem, Colorectal Neoplasia, RNA Markers and Hemoglobin detection
ApplicantGeneoscopy, Inc.
2220 Welsch Industrial Ct.
St. Louis, MO 63146
PMA NumberP230001
Supplement NumberS001
Date Received05/24/2024
Decision Date08/23/2024
Product Code SBB 
Advisory Committee Pathology
Supplement TypeReal-Time Process
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval to use a different blocking reagent.
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