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FDA 510(k)

Navios EX 流式细胞仪，6色/2激光，Navios EX 流式细胞仪，8色/2激光，Navios EX 流式细胞仪，10色/3激光

K号: K162897 · 2017-06-23

申请人Beckman Coulter
决定日期2017-06-23
产品代码OYE
咨询委员会HE 请注意，由于您只提供了“HE”作为输入，我无法提供完整的翻译。请提供完整的描述或文本，以便我能够进行准确的翻译。
决定实质等同

器械摘要

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.

常见问题

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.

相关临床试验

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Beckman Coulter为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K232904Access 酶解素K193124Unicel DxH 800 Coulter 细胞分析系统K182886Cytomics FC 500系列（MPL或MCL）流式细胞仪K183592ClearLLab 10C 面板（B，T，M1，M2），Navios 流式细胞仪，Navios EX 流式细胞仪K181599Unicel DxH 800 细胞分析系统及早期脓毒症指示器应用K181475DxH 520血液分析仪

查看所有 7 个设备 →

相关器械（代码：OYE）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K232600DxFLEX流式细胞仪；ClearLLab 10C面板Beckman Coulter, Inc.K201814BD FACSLyric 流式细胞仪（3-1, 4-2, 4-2-2, 4-3-3 和 4-3-5 光学配置），BD FACSDuet 样品制备系统，BD FACS Universal Loader，BD FACSuite 临床软件，BD Multitest 6-色检测模块，BD Multitest 4-色检测模块，BD FACSFlow 套管流体，BD CS&T 球珠，BD FC 球珠 7-色套件Becton, Dickinson and CompanyK170974BD FACSLyric 流式细胞仪（3-1, 4-2, 4-2-2 和 4-3-3 光学配置），BD FACSuite 临床软件，BD Multitest 6-色检测，BD Multitest 4-色检测，BD Multitest 6-色 TBNKBecton, Dickinson and Company

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。

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