BRACAnalysis CDx
FDA premarket approval P140020/S017 · decided 2018-10-25
Approval details
- PMA number
- P140020
- Supplement
- S017
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- BRACAnalysis CDx
- Generic name
- Cancer-related germline gene mutation detection system
- Applicant
- Myriad Genetic Laboratories
- Date received
- 2018-07-31
- Decision date
- 2018-10-25
- Days to decision
- 86 days
- Decision code
- APPR
- Product code
- PJG
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Salt Lake Cit, UT
- Statement
- Approval to reduce the number of samples for PQ for like-for-like instruments replacement
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