PMA P190014S006
- Device
- myChoice CDx
- Applicant
- Myriad Genetic Laboratories, Inc.
- PMA number
- P190014
- Supplement
- S006
- Product code
- PJG
- Decision date
- 2022-02-10
- Generic name
- Cancer-related germline gene mutation detection system
- Approval order statement
- Approval of an upgraded version of MyChoice CDx (version 2) due to reagent change to the device.
Current openFDA PMA Record#
- Device
- myChoice CDx
- Applicant
- Myriad Genetic Laboratories, Inc.
- PMA number
- P190014
- Supplement
- S006
- Product code
- PJG
- Generic name
- Cancer-related germline gene mutation detection system
- Decision date
- 2022-02-10
- Decision code
- APPR
- Date received
- 2021-06-07
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval of an upgraded version of MyChoice CDx (version 2) due to reagent change to the device.