|
Device | Praxis Extended RAS Panel |
Generic Name | Next generation sequencing oncology panel, somatic or germline variant detection system |
Applicant | Illumina, Inc. 5200 ILLUMINA WAY SAN DIEGO, CA 92122 |
PMA Number | P160038 |
Supplement Number | S006 |
Date Received | 08/24/2018 |
Decision Date | 09/20/2018 |
Withdrawal Date
|
12/22/2023 |
Product Code |
PQP |
Advisory Committee |
Pathology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Incorporate a new in-process QC test for reagent functionality. |