BRACAnalysis CDx®
FDA premarket approval P140020/S026 · decided 2023-01-27
Approval details
- PMA number
- P140020
- Supplement
- S026
- 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
- 2023-01-11
- Decision date
- 2023-01-27
- Days to decision
- 16 days
- Decision code
- OK30
- Product code
- PJG
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Salt Lake Cit, UT
- Statement
- Extension of lab space.
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