PMA P160040S013
- Device
- LeukoStrat CDx FLT3 Mutation Assay
- Applicant
- Invivoscribe Technologies, Inc.
- PMA number
- P160040
- Supplement
- S013
- Product code
- OWD
- Decision date
- 2024-09-27
- Classification
- Pathology
- Generic name
- Somatic gene mutation detection system
- Approval order statement
- approval for use of any cell counter for use with the LeukoStrat CDx FLT3 Mutation Assay
Current openFDA PMA Record#
- Device
- LeukoStrat CDx FLT3 Mutation Assay
- Applicant
- Invivoscribe Technologies, Inc.
- PMA number
- P160040
- Supplement
- S013
- Product code
- OWD
- Generic name
- Somatic gene mutation detection system
- Decision date
- 2024-09-27
- Decision code
- APPR
- Date received
- 2024-09-04
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- approval for use of any cell counter for use with the LeukoStrat CDx FLT3 Mutation Assay