|
Device | myChoice HRD CDx |
Generic Name | Cancer-related germline gene mutation detection system |
Applicant | Myriad Genetic Laboratories, Inc 320 Wankara Way Salt Lake City, UT 84108 |
PMA Number | P190014 |
Supplement Number | S005 |
Date Received | 05/28/2021 |
Decision Date | 06/24/2021 |
Product Code |
PJG |
Advisory Committee |
Pathology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for an update to the contamination detection algorithm which is a quality control change to the myChoice CDx device software. |