Cue COVID-19 分子测试
K号: K232643 · 2023-11-28
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决定日期2023-11-28
产品代码QWB
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器械摘要
Cue COVID-19 Molecular Test is the device name listed in this FDA 510(k) record. The listed applicant is Cue Health, Inc.. It received FDA 510(k) clearance on 2023-11-28 under 510(k) number K232643. The device is classified under product code QWB. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Cue COVID-19 Molecular Test?
Cue COVID-19 Molecular Test is a medical device that received FDA 510(k) clearance on 2023-11-28. The listed applicant is Cue Health, Inc.. The 510(k) number is K232643.
When did Cue COVID-19 Molecular Test receive FDA 510(k) clearance?
Cue COVID-19 Molecular Test received FDA 510(k) clearance on 2023-11-28, under 510(k) number K232643.
Who is the listed applicant for Cue COVID-19 Molecular Test?
The FDA 510(k) record lists Cue Health, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Cue COVID-19 Molecular Test?
The FDA product code for Cue COVID-19 Molecular Test is QWB.
相关临床试验
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相关器械（代码：QWB）
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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