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FDA 510(k)

Navios EX 流式細胞儀，6 色光/2 激光，Navios EX 流式細胞儀，8 色光/2 激光，Navios EX 流式細胞儀，10 色光/3 激光

K 號：K162897 · 2017-06-23

申請人Beckman Coulter
決定日期2017-06-23
產品代碼OYE
諮詢委員會HE 請提供完整的描述文本，以便我能夠進行翻譯。
決定相當於

器材摘要

Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2 Laser, Navios EX Flow Cytometer, 10 Color/3 Laser is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter. It received FDA 510(k) clearance on 2017-06-23 under 510(k) number K162897. The device is classified under product code OYE. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2 Laser, Navios EX Flow Cytometer, 10 Color/3 Laser?

Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2 Laser, Navios EX Flow Cytometer, 10 Color/3 Laser is a medical device that received FDA 510(k) clearance on 2017-06-23. The listed applicant is Beckman Coulter. The 510(k) number is K162897.

When did Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2 Laser, Navios EX Flow Cytometer, 10 Color/3 Laser receive FDA 510(k) clearance?

Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2 Laser, Navios EX Flow Cytometer, 10 Color/3 Laser received FDA 510(k) clearance on 2017-06-23, under 510(k) number K162897.

Who is the listed applicant for Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2 Laser, Navios EX Flow Cytometer, 10 Color/3 Laser?

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

What is the FDA product code for Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2 Laser, Navios EX Flow Cytometer, 10 Color/3 Laser?

The FDA product code for Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2 Laser, Navios EX Flow Cytometer, 10 Color/3 Laser is OYE.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Beckman Coulter 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。

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相關器械（代碼：OYE）

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。

K232600DxFLEX 流式細胞儀；ClearLLab 10C 面板Beckman Coulter, Inc.K201814BD FACSLyric 流式細胞儀（3-1、4-2、4-2-2、4-3-3 和 4-3-5 光學配置），BD FACSDuet 樣本製備系統，BD FACS Universal Loader，BD FACSuite 醫療軟體，BD Multitest 6-Color 檢測模組，BD Multitest 4-Color 檢測模組，BD FACSFlow Sheath 液體，BD CS&T Beads，BD FC Beads 7-Color 套件Becton, Dickinson and CompanyK170974BD FACSLyric 流式細胞儀（3-1, 4-2, 4-2-2 及 4-3-3 光學配置），BD FACSuite 醫療軟體，BD Multitest 6-Color 檢測，BD Multitest 4-Color 檢測，BD Multitest 6-Color TBNKBecton, Dickinson and Company

官方來源

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