- Device
- myChoice HRD CDx
- Applicant
- Myriad Genetic Laboratories, Inc.
- PMA number
- P190014
- Supplement
- S005
- Product code
- PJG
- Generic name
- Cancer-related germline gene mutation detection system
- Decision date
- 2021-06-24
- Decision code
- APPR
- Date received
- 2021-05-28
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for an update to the contamination detection algorithm which is a quality control change to the myChoice CDx device software.