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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.
 
DeviceLeukoStrat CDx FLT3 Mutation Assay
Generic NameSomatic gene mutation detection system
ApplicantINVIVOSCRIBE TECHNOLOGIES, INC
10222 Barnes Canyon Road, Building 1
San Diego, CA 92121
PMA NumberP160040
Supplement NumberS007
Date Received12/02/2020
Decision Date08/26/2021
Product Code OWD 
Advisory Committee Pathology
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the improvement of the manufacturing method for the FLT3 TKD Positive Control included with the LeukoStrat CDx FLT3 Mutation Assay.
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