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FDA 510(k)

ACTOnco，ACTOnco IVD

K 號：K210017 · 2022-12-23

申請人Act Genomics
決定日期2022-12-23
產品代碼PZM
諮詢委員會PA
決定相當於

器材摘要

ACTOnco, ACTOnco IVD is the device name listed in this FDA 510(k) record. The listed applicant is Act Genomics. It received FDA 510(k) clearance on 2022-12-23 under 510(k) number K210017. The device is classified under product code PZM. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ACTOnco, ACTOnco IVD?

ACTOnco, ACTOnco IVD is a medical device that received FDA 510(k) clearance on 2022-12-23. The listed applicant is Act Genomics. The 510(k) number is K210017.

When did ACTOnco, ACTOnco IVD receive FDA 510(k) clearance?

ACTOnco, ACTOnco IVD received FDA 510(k) clearance on 2022-12-23, under 510(k) number K210017.

Who is the listed applicant for ACTOnco, ACTOnco IVD?

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

What is the FDA product code for ACTOnco, ACTOnco IVD?

The FDA product code for ACTOnco, ACTOnco IVD is PZM.

相關臨床試驗

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相關器械（代碼：PZM）

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。

K260235CellDx-組織Datar Cancer Genetics Private LimitedK241868xR IVDTempus AI, Inc.K250003GENESEEQPRIME NGS 癌症分析試劑 (FFPE) (GS6005)Geneseeq Technology, Inc.K202304紐約大學朗格尼基因PACT（可行癌症目標基因輪廓）Nyu Langone Medical CenterK192063PGDx elio 組織完整Personal Genome DiagnosticsK190661Omics CoreNanthealth, Inc.

官方來源

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