PMA P160038S002
- Device
- Praxis Extended RAS Panel
- Applicant
- Illumina, Inc.
- PMA number
- P160038
- Supplement
- S002
- Product code
- PQP
- Decision date
- 2018-03-26
- Classification
- Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Approval order statement
- Approval for the implementation of 100% visual volume inspection of the filled containers.
Current openFDA PMA Record#
- Device
- Praxis Extended RAS Panel
- Applicant
- Illumina, Inc.
- PMA number
- P160038
- Supplement
- S002
- Product code
- PQP
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Decision date
- 2018-03-26
- Decision code
- APPR
- Date received
- 2018-03-05
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the implementation of 100% visual volume inspection of the filled containers.