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FDA 510(k)

BD 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

K 號：K201814 · 2020-09-28

申請人Becton, Dickinson and Company
決定日期2020-09-28
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

BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2, 4-3-3 and 4-3-5 optical configurations), BD FACSDuet Sample Preparation System, BD FACS Universal Loader, BD FACSuite Clinical software, BD Multitest 6-Color Assay Modules, BD Multitest 4-Color Assay Modules, BD FACSFlow Sheath Fluid, BD CS&T Beads, BD FC Beads 7-Color Kit is the device name listed in this FDA 510(k) record. The listed applicant is Becton, Dickinson and Company. It received FDA 510(k) clearance on 2020-09-28 under 510(k) number K201814. 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 BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2, 4-3-3 and 4-3-5 optical configurations), BD FACSDuet Sample Preparation System, BD FACS Universal Loader, BD FACSuite Clinical software, BD Multitest 6-Color Assay Modules, BD Multitest 4-Color Assay Modules, BD FACSFlow Sheath Fluid, BD CS&T Beads, BD FC Beads 7-Color Kit?

BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2, 4-3-3 and 4-3-5 optical configurations), BD FACSDuet Sample Preparation System, BD FACS Universal Loader, BD FACSuite Clinical software, BD Multitest 6-Color Assay Modules, BD Multitest 4-Color Assay Modules, BD FACSFlow Sheath Fluid, BD CS&T Beads, BD FC Beads 7-Color Kit is a medical device that received FDA 510(k) clearance on 2020-09-28. The listed applicant is Becton, Dickinson and Company. The 510(k) number is K201814.

When did BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2, 4-3-3 and 4-3-5 optical configurations), BD FACSDuet Sample Preparation System, BD FACS Universal Loader, BD FACSuite Clinical software, BD Multitest 6-Color Assay Modules, BD Multitest 4-Color Assay Modules, BD FACSFlow Sheath Fluid, BD CS&T Beads, BD FC Beads 7-Color Kit receive FDA 510(k) clearance?

BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2, 4-3-3 and 4-3-5 optical configurations), BD FACSDuet Sample Preparation System, BD FACS Universal Loader, BD FACSuite Clinical software, BD Multitest 6-Color Assay Modules, BD Multitest 4-Color Assay Modules, BD FACSFlow Sheath Fluid, BD CS&T Beads, BD FC Beads 7-Color Kit received FDA 510(k) clearance on 2020-09-28, under 510(k) number K201814.

Who is the listed applicant for BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2, 4-3-3 and 4-3-5 optical configurations), BD FACSDuet Sample Preparation System, BD FACS Universal Loader, BD FACSuite Clinical software, BD Multitest 6-Color Assay Modules, BD Multitest 4-Color Assay Modules, BD FACSFlow Sheath Fluid, BD CS&T Beads, BD FC Beads 7-Color Kit?

The FDA 510(k) record lists Becton, Dickinson and Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2, 4-3-3 and 4-3-5 optical configurations), BD FACSDuet Sample Preparation System, BD FACS Universal Loader, BD FACSuite Clinical software, BD Multitest 6-Color Assay Modules, BD Multitest 4-Color Assay Modules, BD FACSFlow Sheath Fluid, BD CS&T Beads, BD FC Beads 7-Color Kit?

The FDA product code for BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2, 4-3-3 and 4-3-5 optical configurations), BD FACSDuet Sample Preparation System, BD FACS Universal Loader, BD FACSuite Clinical software, BD Multitest 6-Color Assay Modules, BD Multitest 4-Color Assay Modules, BD FACSFlow Sheath Fluid, BD CS&T Beads, BD FC Beads 7-Color Kit is OYE.

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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.K170974BD 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 CompanyK162897Navios 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Beckman Coulter

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