FDA 510(k)

Sofia RSV FIA在Sofia 2分析仪上

K号: K162911 · 2017-02-22

决定日期2017-02-22

产品代码GQG

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决定实质等同

器械摘要

Sofia RSV FIA on Sofia 2 analyzer is the device name listed in this FDA 510(k) record. The listed applicant is Quidel Corporation. It received FDA 510(k) clearance on 2017-02-22 under 510(k) number K162911. The device is classified under product code GQG. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Sofia RSV FIA on Sofia 2 analyzer?

Sofia RSV FIA on Sofia 2 analyzer is a medical device that received FDA 510(k) clearance on 2017-02-22. The listed applicant is Quidel Corporation. The 510(k) number is K162911.

When did Sofia RSV FIA on Sofia 2 analyzer receive FDA 510(k) clearance?

Sofia RSV FIA on Sofia 2 analyzer received FDA 510(k) clearance on 2017-02-22, under 510(k) number K162911.

Who is the listed applicant for Sofia RSV FIA on Sofia 2 analyzer?

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 Sofia RSV FIA on Sofia 2 analyzer?

The FDA product code for Sofia RSV FIA on Sofia 2 analyzer is GQG.

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。

K231795QuickVue COVID-19 测试 K232286Savanna HSV 1+2/VZV 测定，Savanna HSV 1+2/VZV 控制套件，Savanna 仪器 K233688Sofia 2 SARS抗原+ FIA；Sofia 2 SARS抗原+ FIA控制拭子套装 K230349Lyra RSV+hMPV 检测 K230236Lyra A+B 流感病毒检测 K211342Sofia 2 营养性弧菌FIA

查看所有 22 个设备 →

官方来源

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