立克次氏体实时PCR检测
K号: K170940 · 2017-06-29
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决定日期2017-06-29
产品代码PVQ
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器械摘要
Rickettsia Real-time PCR Assay is the device name listed in this FDA 510(k) record. The listed applicant is Centers For Disease Control and Prevention (CDC). It received FDA 510(k) clearance on 2017-06-29 under 510(k) number K170940. The device is classified under product code PVQ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Rickettsia Real-time PCR Assay?
Rickettsia Real-time PCR Assay is a medical device that received FDA 510(k) clearance on 2017-06-29. The listed applicant is Centers For Disease Control and Prevention (CDC). The 510(k) number is K170940.
When did Rickettsia Real-time PCR Assay receive FDA 510(k) clearance?
Rickettsia Real-time PCR Assay received FDA 510(k) clearance on 2017-06-29, under 510(k) number K170940.
Who is the listed applicant for Rickettsia Real-time PCR Assay?
The FDA 510(k) record lists Centers For Disease Control and Prevention (CDC) as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Rickettsia Real-time PCR Assay?
The FDA product code for Rickettsia Real-time PCR Assay is PVQ.
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列明Centers For Disease Control and Prevention (CDC)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。
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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