510(k) Report

FDA applicant

Myriad Genetic Laboratories

Salt Lake Cit2 decisions2014–20190 recalls

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, last Nov 3, 2026

FIG. A — Illustration, pathology panel, where it files most

How often FDA has decided Myriad Genetic Laboratories’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2014: 12019: 1
2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Myriad Genetic Laboratories by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Myriad”

FDA records each applicant name separately; these may or may not be the same firm.