BRACAnalysis CDx
FDA premarket approval P140020/S021 · decided 2021-07-02
Approval details
- PMA number
- P140020
- Supplement
- S021
- 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
- 2021-06-04
- Decision date
- 2021-07-02
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- PJG
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Salt Lake Cit, UT
- Statement
- Replacement of a confirmatory test reagent.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.