MyChoice CDx
FDA premarket approval P190014/S009 · decided 2024-08-29
Approval details
- PMA number
- P190014
- Supplement
- S009
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MyChoice CDx
- Generic name
- Cancer-related germline gene mutation detection system
- Applicant
- Myriad Genetic Laboratories, Inc.
- Date received
- 2024-04-22
- Decision date
- 2024-08-29
- Days to decision
- 129 days
- Decision code
- APPR
- Product code
- PJG
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Salt Lake City, UT
- Statement
- Approval for reagent expiration date extension of Capture Probes and Index Adapters
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