BRACANALYSIS CDx
FDA premarket approval P140020/S007 · decided 2016-06-17
Approval details
- PMA number
- P140020
- Supplement
- S007
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BRACANALYSIS CDx
- Generic name
- Cancer-related germline gene mutation detection system
- Applicant
- Myriad Genetic Laboratories
- Date received
- 2016-06-07
- Decision date
- 2016-06-17
- Days to decision
- 10 days
- Decision code
- APPR
- Product code
- PJG
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Salt Lake Cit, UT
- Statement
- Approval to remove the DNA extraction system from serialization, and to remove non-critical instruments from the specified device components.
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