MyChoice® CDx
FDA premarket approval P190014/S008 · decided 2023-10-27
Approval details
- PMA number
- P190014
- Supplement
- S008
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MyChoice® CDx
- Applicant
- Myriad Genetic Laboratories, Inc.
- Date received
- 2023-01-20
- Decision date
- 2023-10-27
- Days to decision
- 280 days
- Decision code
- APPR
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Salt Lake City, UT
- Statement
- Approval to replace the Illumina HiSeq 2500 Sequencer with the Illumina Next-generation Sequencer (NovaSeq 6000) for MyChoice CDx device.
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