myChoice CDx
FDA premarket approval P190014/S006 · decided 2022-02-10
Approval details
- PMA number
- P190014
- Supplement
- S006
- Supplement type
- Normal 180 Day Track
- 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
- 2021-06-07
- Decision date
- 2022-02-10
- Days to decision
- 248 days
- Decision code
- APPR
- Product code
- PJG
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Salt Lake City, UT
- Statement
- Approval of an upgraded version of MyChoice CDx (version 2) due to reagent change to the device.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.