ACR LAB 尿液分析测试系统
K号: K182384 · 2019-07-26
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决定日期2019-07-26
产品代码JFY
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
ACR LAB Urine Analysis Test System is the device name listed in this FDA 510(k) record. The listed applicant is Healthy.Io, Ltd.. It received FDA 510(k) clearance on 2019-07-26 under 510(k) number K182384. The device is classified under product code JFY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the ACR LAB Urine Analysis Test System?
ACR LAB Urine Analysis Test System is a medical device that received FDA 510(k) clearance on 2019-07-26. The listed applicant is Healthy.Io, Ltd.. The 510(k) number is K182384.
When did ACR LAB Urine Analysis Test System receive FDA 510(k) clearance?
ACR LAB Urine Analysis Test System received FDA 510(k) clearance on 2019-07-26, under 510(k) number K182384.
Who is the listed applicant for ACR LAB Urine Analysis Test System?
The FDA 510(k) record lists Healthy.Io, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ACR LAB Urine Analysis Test System?
The FDA product code for ACR LAB Urine Analysis Test System is JFY.
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Healthy.Io, Ltd.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：JFY）
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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