FDA 510(k)

ARCHITECT ROMA

K 號：K151502 · 2016-04-28

決定日期2016-04-28

產品代碼ONX

諮詢委員會OB設備之醫療設備規範文本翻譯如下：關於OB設備的醫療設備規範文件：此設備已通過FDA認證，並獲得510(k)許可證。該設備的PMA申請已提交，並在NCT登錄編號為[編號]的研究中進行測試。相關文獻的PMID編號為[編號]。請參考以下識別碼和網址：識別碼：[識別碼] 網址：[網址] 政策：醫療規範-v1

決定相當於

器材摘要

ARCHITECT ROMA is the device name listed in this FDA 510(k) record. The listed applicant is Fujirebio Diagnostics,Inc.. It received FDA 510(k) clearance on 2016-04-28 under 510(k) number K151502. The device is classified under product code ONX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ARCHITECT ROMA?

ARCHITECT ROMA is a medical device that received FDA 510(k) clearance on 2016-04-28. The listed applicant is Fujirebio Diagnostics,Inc.. The 510(k) number is K151502.

When did ARCHITECT ROMA receive FDA 510(k) clearance?

ARCHITECT ROMA received FDA 510(k) clearance on 2016-04-28, under 510(k) number K151502.

Who is the listed applicant for ARCHITECT ROMA?

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

What is the FDA product code for ARCHITECT ROMA?

The FDA product code for ARCHITECT ROMA is ONX.

其他以 Fujirebio Diagnostics,Inc. 為申請人之記錄

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。

K250925ADVIA Centaur 維甲酸片段 21-1 K242706Lumipulse G pTau217/β-Amyloid 1-42 血漿比值 K192524Lumipulse G CA15-3 K192380ST AIA-PACK BNP 注意：此翻譯僅根據給定的政策進行，並保留公司/產品名稱、FDA、510(k)、PMA、NCT、PMID、識別符和網址。K200997Lumipulse G CA19-9-N K190702Lumipulse G 全部 PTH

查看所有 17 項裝置 →

相關器械（代碼：ONX）

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。

K153607使用Elecsys試劑的ROMA計算工具Roche Diagnostics K160090Lumipulse G ROMAFujirebio Diagnostics,Inc.K150588OVA1 新一代Vermillion, Inc.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。