QScout Lab；QScout RLD
K号: K230878 · 2023-11-14
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决定日期2023-11-14
产品代码GKZ
咨询委员会HE
请注意，由于您只提供了“HE”作为输入，我无法提供完整的翻译。请提供完整的描述或文本，以便我能够进行准确的翻译。
决定实质等同
器械摘要
QScout Lab; QScout RLD is the device name listed in this FDA 510(k) record. The listed applicant is Ad Astra Diagnostics, Inc.. It received FDA 510(k) clearance on 2023-11-14 under 510(k) number K230878. The device is classified under product code GKZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the QScout Lab; QScout RLD?
QScout Lab; QScout RLD is a medical device that received FDA 510(k) clearance on 2023-11-14. The listed applicant is Ad Astra Diagnostics, Inc.. The 510(k) number is K230878.
When did QScout Lab; QScout RLD receive FDA 510(k) clearance?
QScout Lab; QScout RLD received FDA 510(k) clearance on 2023-11-14, under 510(k) number K230878.
Who is the listed applicant for QScout Lab; QScout RLD?
The FDA 510(k) record lists Ad Astra Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for QScout Lab; QScout RLD?
The FDA product code for QScout Lab; QScout RLD is GKZ.
相关临床试验
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相关器械（代码：GKZ）
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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