DxFLEX流式细胞仪；ClearLLab 10C面板
K号: K232600 · 2023-11-22
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决定日期2023-11-22
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
DxFLEX Flow Cytometer; ClearLLab 10C Panels is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2023-11-22 under 510(k) number K232600. 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 DxFLEX Flow Cytometer; ClearLLab 10C Panels?
DxFLEX Flow Cytometer; ClearLLab 10C Panels is a medical device that received FDA 510(k) clearance on 2023-11-22. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K232600.
When did DxFLEX Flow Cytometer; ClearLLab 10C Panels receive FDA 510(k) clearance?
DxFLEX Flow Cytometer; ClearLLab 10C Panels received FDA 510(k) clearance on 2023-11-22, under 510(k) number K232600.
Who is the listed applicant for DxFLEX Flow Cytometer; ClearLLab 10C Panels?
FDA 510(k)记录中列出Beckman Coulter, Inc.为申请人。这本身并不能确立该设备制造商的身份。
What is the FDA product code for DxFLEX Flow Cytometer; ClearLLab 10C Panels?
The FDA product code for DxFLEX Flow Cytometer; ClearLLab 10C Panels 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。
列明Beckman Coulter, Inc.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。
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。
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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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