PMA P140020S013
- Device
- BRACAnalysis CDx Device
- Applicant
- Myriad Genetic Laboratories
- PMA number
- P140020
- Supplement
- S013
- Product code
- PJG
- Decision date
- 2017-10-26
- Classification
- Cancer-related Germline Gene Mutation Detection System
- Generic name
- Cancer-related germline gene mutation detection system
- Approval order statement
- Expansion of laboratory space.
Current openFDA PMA Record#
- Device
- BRACAnalysis CDx Device
- Applicant
- Myriad Genetic Laboratories
- PMA number
- P140020
- Supplement
- S013
- Product code
- PJG
- Generic name
- Cancer-related germline gene mutation detection system
- Decision date
- 2017-10-26
- Decision code
- OK30
- Date received
- 2017-09-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Expansion of laboratory space.