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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 NumberS010
Date Received03/15/2022
Decision Date04/11/2022
Product Code OWD 
Advisory Committee Pathology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Change of contractor mycoplasma testing method for Invivoscribe cell lines.
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