PMA P160038S001
- Device
- Praxis Extended RAS Panel
- Applicant
- Illumina, Inc.
- PMA number
- P160038
- Supplement
- S001
- Product code
- PQP
- Decision date
- 2018-04-11
- 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
- Changes in analytical test methods and removal of a redundant in-process test.
Current openFDA PMA Record#
- Device
- Praxis Extended RAS Panel
- Applicant
- Illumina, Inc.
- PMA number
- P160038
- Supplement
- S001
- Product code
- PQP
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Decision date
- 2018-04-11
- Decision code
- OK30
- Date received
- 2018-03-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes in analytical test methods and removal of a redundant in-process test.