PMA P160040S009
- Device
- LeukoStrat CDx FLT3 Mutation Assay
- Applicant
- Invivoscribe Technologies, Inc.
- PMA number
- P160040
- Supplement
- S009
- Product code
- OWD
- Decision date
- 2021-08-11
- Generic name
- Somatic gene mutation detection system
- Approval order statement
- Qualification of an automated process for fill, finish, and label the kit components.
Current openFDA PMA Record#
- Device
- LeukoStrat CDx FLT3 Mutation Assay
- Applicant
- Invivoscribe Technologies, Inc.
- PMA number
- P160040
- Supplement
- S009
- Product code
- OWD
- Generic name
- Somatic gene mutation detection system
- Decision date
- 2021-08-11
- Decision code
- OK30
- Date received
- 2021-07-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Qualification of an automated process for fill, finish, and label the kit components.