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FDA PMA

Cancer-related germline gene mutation detection system

PMA Number: P190014 · 2026-03-10

ApplicantMyriad Genetic Laboratories, Inc.
Decision Date2026-03-10
PMA NumberP190014
Product CodePJG
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteePA

Device Summary

Cancer-related germline gene mutation detection system is the device name listed in this FDA 510(k) record. The listed applicant is Myriad Genetic Laboratories, Inc.. It received FDA 510(k) clearance on 2026-03-10. The device is classified under product code PJG. It was reviewed by the PA advisory panel.

Frequently Asked Questions

What is the Cancer-related germline gene mutation detection system?

Cancer-related germline gene mutation detection system is a medical device that received FDA 510(k) clearance on 2026-03-10. The listed applicant is Myriad Genetic Laboratories, Inc..

When did Cancer-related germline gene mutation detection system receive FDA 510(k) clearance?

The clearance date for Cancer-related germline gene mutation detection system can be found in the official FDA records.

Who is the listed applicant for Cancer-related germline gene mutation detection system?

The FDA 510(k) record lists Myriad Genetic Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cancer-related germline gene mutation detection system?

The FDA product code for Cancer-related germline gene mutation detection system is PJG.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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