PMA P190014S010
- Device
- MyChoice® CDx
- Applicant
- Myriad Genetic Laboratories, Inc.
- PMA number
- P190014
- Supplement
- S010
- Product code
- PJG
- Decision date
- 2024-10-04
- Classification
- Pathology
- Generic name
- Cancer-related germline gene mutation detection system
- Approval order statement
- Approval of manufacturing site change for MyChoice® CDx
Current openFDA PMA Record#
- Device
- MyChoice® CDx
- Applicant
- Myriad Genetic Laboratories, Inc.
- PMA number
- P190014
- Supplement
- S010
- Product code
- PJG
- Generic name
- Cancer-related germline gene mutation detection system
- Decision date
- 2024-10-04
- Decision code
- APPR
- Date received
- 2024-06-14
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval of manufacturing site change for MyChoice® CDx