ACESO 早期妊娠测试
K号: K234152 · 2024-04-05
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决定日期2024-04-05
产品代码LCX
咨询委员会CH
请注意，您提供的文本“CH”不足以进行翻译。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。
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器械摘要
ACESO Early Pregnancy Test is the device name listed in this FDA 510(k) record. The listed applicant is Aceso Laboratories, Inc.. It received FDA 510(k) clearance on 2024-04-05 under 510(k) number K234152. The device is classified under product code LCX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the ACESO Early Pregnancy Test?
ACESO Early Pregnancy Test is a medical device that received FDA 510(k) clearance on 2024-04-05. The listed applicant is Aceso Laboratories, Inc.. The 510(k) number is K234152.
When did ACESO Early Pregnancy Test receive FDA 510(k) clearance?
ACESO Early Pregnancy Test received FDA 510(k) clearance on 2024-04-05, under 510(k) number K234152.
Who is the listed applicant for ACESO Early Pregnancy Test?
The FDA 510(k) record lists Aceso Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ACESO Early Pregnancy Test?
The FDA product code for ACESO Early Pregnancy Test is LCX.
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。
相关器械（代码：LCX）
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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