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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
Classification Namesomatic gene mutation detection system
Generic Namesomatic gene mutation detection system
Applicant
INVIVOSCRIBE TECHNOLOGIES, INC
6330 nancy ridge drive
suite 106
san diego, CA 92121
PMA NumberP160040
Supplement NumberS001
Date Received12/22/2017
Decision Date01/19/2018
Product Code
OWD[ Registered Establishments with 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 
Validation of the ABI instruments and minor corrections to the instructions for use.
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