Lyra RSV+hMPV 检测
K号: K230349 · 2023-03-10
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决定日期2023-03-10
产品代码OEM
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器械摘要
Lyra RSV+hMPV Assay is the device name listed in this FDA 510(k) record. The listed applicant is Quidel Corporation. It received FDA 510(k) clearance on 2023-03-10 under 510(k) number K230349. The device is classified under product code OEM. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Lyra RSV+hMPV Assay?
Lyra RSV+hMPV Assay is a medical device that received FDA 510(k) clearance on 2023-03-10. The listed applicant is Quidel Corporation. The 510(k) number is K230349.
When did Lyra RSV+hMPV Assay receive FDA 510(k) clearance?
Lyra RSV+hMPV Assay received FDA 510(k) clearance on 2023-03-10, under 510(k) number K230349.
Who is the listed applicant for Lyra RSV+hMPV Assay?
The FDA 510(k) record lists Quidel Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Lyra RSV+hMPV Assay?
The FDA product code for Lyra RSV+hMPV Assay is OEM.
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列明Quidel Corporation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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