PMA P160040S010
- Device
- LeukoStrat CDx FLT3 Mutation Assay
- Applicant
- Invivoscribe Technologies, Inc.
- PMA number
- P160040
- Supplement
- S010
- Product code
- OWD
- Decision date
- 2022-04-11
- Generic name
- Somatic gene mutation detection system
- Approval order statement
- Change of contractor mycoplasma testing method for Invivoscribe cell lines.
Current openFDA PMA Record#
- Device
- LeukoStrat CDx FLT3 Mutation Assay
- Applicant
- Invivoscribe Technologies, Inc.
- PMA number
- P160040
- Supplement
- S010
- Product code
- OWD
- Generic name
- Somatic gene mutation detection system
- Decision date
- 2022-04-11
- Decision code
- OK30
- Date received
- 2022-03-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change of contractor mycoplasma testing method for Invivoscribe cell lines.