FDA applicant
Myriad Genetic Laboratories
FDA records 2 decisions for Myriad Genetic Laboratories (Salt Lake Cit) from 2014 to 2019: 2 original PMA approvals. All are in product code PJG (Cancer-Related Germline Gene Mutation…). No recall is linked to its devices.
FDA’s records also spell it “Myriad Genetic Laboratories, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Myriad Genetic Laboratories’s devices, and how often a recall has named them.
FDA decisions per year
1in 2019
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2014.
Planning a device like Myriad Genetic Laboratories’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Myriad”
FDA records each applicant name separately; these may or may not be the same firm.