EarliPoint系统
K号: K243891 · 2025-03-26
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决定日期2025-03-26
产品代码QPF
咨询委员会NE
请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
决定实质等同
器械摘要
EarliPoint System is the device name listed in this FDA 510(k) record. The listed applicant is Earlitec Diagnostics. It received FDA 510(k) clearance on 2025-03-26 under 510(k) number K243891. The device is classified under product code QPF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the EarliPoint System?
EarliPoint System is a medical device that received FDA 510(k) clearance on 2025-03-26. The listed applicant is Earlitec Diagnostics. The 510(k) number is K243891.
When did EarliPoint System receive FDA 510(k) clearance?
EarliPoint System received FDA 510(k) clearance on 2025-03-26, under 510(k) number K243891.
Who is the listed applicant for EarliPoint System?
The FDA 510(k) record lists Earlitec Diagnostics as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for EarliPoint System?
The FDA product code for EarliPoint System is QPF.
相关临床试验
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列明Earlitec Diagnostics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：QPF）
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。
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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