BRACAnalysis CDx®
FDA premarket approval P140020/S024 · decided 2022-11-10
Approval details
- PMA number
- P140020
- Supplement
- S024
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BRACAnalysis CDx®
- Generic name
- Cancer-related germline gene mutation detection system
- Applicant
- Myriad Genetic Laboratories
- Date received
- 2022-10-14
- Decision date
- 2022-11-10
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- PJG
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Salt Lake Cit, UT
- Statement
- Modification of a buffer.
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