Emit II Plus 可卡因代谢物检测
K号: K170293 · 2017-10-25
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决定日期2017-10-25
产品代码DIO
咨询委员会TX
请注意，由于您没有提供具体的医疗设备监管文本，我无法进行翻译。请提供具体的文本内容，以便我能够按照您的要求进行翻译。
决定实质等同
器械摘要
Emit II Plus Cocaine Metabolite Assay is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2017-10-25 under 510(k) number K170293. The device is classified under product code DIO. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Emit II Plus Cocaine Metabolite Assay?
Emit II Plus Cocaine Metabolite Assay is a medical device that received FDA 510(k) clearance on 2017-10-25. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K170293.
When did Emit II Plus Cocaine Metabolite Assay receive FDA 510(k) clearance?
Emit II Plus Cocaine Metabolite Assay received FDA 510(k) clearance on 2017-10-25, under 510(k) number K170293.
Who is the listed applicant for Emit II Plus Cocaine Metabolite Assay?
FDA 510(k)记录中列出西门子医疗诊断公司（Siemens Healthcare Diagnostics, Inc.）为申请人。这本身并不足以确立该设备制造商的身份。
What is the FDA product code for Emit II Plus Cocaine Metabolite Assay?
The FDA product code for Emit II Plus Cocaine Metabolite Assay is DIO.
相关临床试验
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列明Siemens Healthcare Diagnostics, 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：DIO）
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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