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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 Rd.
Bldg. 1
San Diego, CA 92121
PMA NumberP160040
Supplement NumberS008
Date Received07/09/2021
Decision Date08/05/2021
Product Code OWD 
Advisory Committee Pathology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval of changes made to the Instructions for Use of the LeukoStrat CDx FLT3 Mutation Assay.
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