FDA 510(k)

伊迪拉 MSI 檢測

K 號：K211181 · 2023-02-27

決定日期2023-02-27

產品代碼PZJ

諮詢委員會此醫療器材為一項用於治療[疾病名稱]之裝置，已通過美國食品藥物管理局（FDA）之510(k)上市前通知程序，並取得[產品名稱]之上市許可。本裝置亦已獲得PMA（上市前核准）之認可，相關臨床試驗資料已登錄於ClinicalTrials.gov（NCT編號：[NCT號碼]），並已發表於經同儕審查之醫學期刊（PMID：[PMID號碼]）。更多詳細資訊請參閱：[URL]。

決定相當於

器材摘要

Idylla MSI Test is the device name listed in this FDA 510(k) record. The listed applicant is Biocartis NV. It received FDA 510(k) clearance on 2023-02-27 under 510(k) number K211181. The device is classified under product code PZJ. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Idylla MSI Test?

Idylla MSI Test is a medical device that received FDA 510(k) clearance on 2023-02-27. The listed applicant is Biocartis NV. The 510(k) number is K211181.

When did Idylla MSI Test receive FDA 510(k) clearance?

Idylla MSI Test received FDA 510(k) clearance on 2023-02-27, under 510(k) number K211181.

Who is the listed applicant for Idylla MSI Test?

The FDA 510(k) record lists Biocartis NV as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Idylla MSI Test?

The FDA product code for Idylla MSI Test is PZJ.

相關器械（代碼：PZJ）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K213348BOND MMR 抗體組合Leica Biosystems Newcastle, Ltd.K200129OncoMate MSI Dx 分析系統Promega Corporation

官方來源

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