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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
Applicant
INVIVOSCRIBE TECHNOLOGIES, INC
10222 barnes canyon road, building 1
san diego, CA 92121
PMA NumberP160040
Supplement NumberS009
Date Received07/12/2021
Decision Date08/11/2021
Product Code OWD 
Advisory Committee Pathology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Qualification of an automated process for fill, finish, and label the kit components.
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