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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
6330 nancy ridge drive
suite 106
san diego, CA 92121
PMA NumberP160040
Supplement NumberS003
Date Received04/12/2018
Decision Date12/07/2018
Product Code
OWD[ Registered Establishments with OWD ]
Advisory Committee Pathology
Supplement Typenormal 180 day track no user fee
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at Invivoscribe Technologies, Inc., 10222 Barnes Canyon Rd., Bldg. 1, San Diego, California.