myChoice HRD CDx
FDA premarket approval P190014/S005 · decided 2021-06-24
Approval details
- PMA number
- P190014
- Supplement
- S005
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- myChoice HRD CDx
- Generic name
- Cancer-related germline gene mutation detection system
- Applicant
- Myriad Genetic Laboratories, Inc.
- Date received
- 2021-05-28
- Decision date
- 2021-06-24
- Days to decision
- 27 days
- Decision code
- APPR
- Product code
- PJG
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Salt Lake City, UT
- Statement
- Approval for an update to the contamination detection algorithm which is a quality control change to the myChoice CDx device software.
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