PMA P190014S009
- Device
- MyChoice CDx
- Applicant
- Myriad Genetic Laboratories, Inc.
- PMA number
- P190014
- Supplement
- S009
- Product code
- PJG
- Decision date
- 2024-08-29
- Classification
- Pathology
- Generic name
- Cancer-related germline gene mutation detection system
- Approval order statement
- Approval for reagent expiration date extension of Capture Probes and Index Adapters
Current openFDA PMA Record#
- Device
- MyChoice CDx
- Applicant
- Myriad Genetic Laboratories, Inc.
- PMA number
- P190014
- Supplement
- S009
- Product code
- PJG
- Generic name
- Cancer-related germline gene mutation detection system
- Decision date
- 2024-08-29
- Decision code
- APPR
- Date received
- 2024-04-22
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for reagent expiration date extension of Capture Probes and Index Adapters