Solana A型+B型流感检测。
K号: K161814 · 2016-09-27
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决定日期2016-09-27
产品代码OCC
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器械摘要
Solana Influenza A+B 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 2016-09-27 under 510(k) number K161814. The device is classified under product code OCC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Solana Influenza A+B Assay?
Solana Influenza A+B Assay is a medical device that received FDA 510(k) clearance on 2016-09-27. The listed applicant is Quidel Corporation. The 510(k) number is K161814.
When did Solana Influenza A+B Assay receive FDA 510(k) clearance?
Solana Influenza A+B Assay received FDA 510(k) clearance on 2016-09-27, under 510(k) number K161814.
Who is the listed applicant for Solana Influenza A+B 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 Solana Influenza A+B Assay?
The FDA product code for Solana Influenza A+B Assay is OCC.
相关临床试验
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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。
相关器械（代码：OCC）
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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