LeukoStrat CDx FLT3 Mutation Assay

FDA Premarket Approval P160040 S010

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.

Pre-market Approval Supplement Details

DeviceLeukoStrat CDx FLT3 Mutation Assay
Generic NameSomatic Gene Mutation Detection System
ApplicantINVIVOSCRIBE TECHNOLOGIES, INC10222 Barnes Canyon Road, Building 1san 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
Date Received2022-03-15
Decision Date2022-04-11
PMAP160040
SupplementS010
Product CodeOWD 
Advisory CommitteePathology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressINVIVOSCRIBE TECHNOLOGIES, INC
10222 Barnes Canyon Road, Building 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 Approval Order Statement  
change Of Contractor Mycoplasma Testing Method For Invivoscribe Cell Lines

Supplemental Filings

Supplement NumberDateSupplement Type
P160040Original Filing
S010 2022-03-15 30-day Notice
S009 2021-07-12 30-day Notice
S008 2021-07-09 Special (immediate Track)
S007
S006 2019-10-17 Normal 180 Day Track
S005
S004 2018-11-06 Real-time Process
S003 2018-04-12 Normal 180 Day Track No User Fee
S002 2018-03-30 Normal 180 Day Track
S001 2017-12-22 30-day Notice

NIH GUDID Devices

Device IDPMASupp
00850052003685 P160040 004
00850052003739 P160040 006
00810022732571 P160040 006

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.