FDA PMA

次世代シークエンシング腫瘍パネル、体細胞または胚細胞変異検出システム

PMA番号：P170019 · 2026-09-16

申請者Foundation Medicine, Inc.

決定日2026-09-16

PMA番号P170019

製品コードPQP

デバイスクラスクラス3

診療科U

諮問委員会PA

医療機器の概要

Next generation sequencing oncology panel, somatic or germline variant detection system is the device name listed in this FDA 510(k) record. The listed applicant is Foundation Medicine, Inc.. It received FDA 510(k) clearance on 2026-09-16. The device is classified under product code PQP. It was reviewed by the PA advisory panel.

よくある質問

What is the Next generation sequencing oncology panel, somatic or germline variant detection system?

Next generation sequencing oncology panel, somatic or germline variant detection system is a medical device that received FDA 510(k) clearance on 2026-09-16. The listed applicant is Foundation Medicine, Inc..

When did Next generation sequencing oncology panel, somatic or germline variant detection system receive FDA 510(k) clearance?

The clearance date for Next generation sequencing oncology panel, somatic or germline variant detection system can be found in the official FDA records.

Who is the listed applicant for Next generation sequencing oncology panel, somatic or germline variant detection system?

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

What is the FDA product code for Next generation sequencing oncology panel, somatic or germline variant detection system?

The FDA product code for Next generation sequencing oncology panel, somatic or germline variant detection system is PQP.

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医療機器の概要

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