Fast PCR Mini 呼吸检测板
K号: K252932 · 2026-06-12
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决定日期2026-06-12
产品代码QOF
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器械摘要
Fast PCR Mini Respiratory Panel is the device name listed in this FDA 510(k) record. The listed applicant is Autonomous Medical Devices Incorporated. It received FDA 510(k) clearance on 2026-06-12 under 510(k) number K252932. The device is classified under product code QOF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Fast PCR Mini Respiratory Panel?
Fast PCR Mini Respiratory Panel is a medical device that received FDA 510(k) clearance on 2026-06-12. The listed applicant is Autonomous Medical Devices Incorporated. The 510(k) number is K252932.
When did Fast PCR Mini Respiratory Panel receive FDA 510(k) clearance?
Fast PCR Mini Respiratory Panel received FDA 510(k) clearance on 2026-06-12, under 510(k) number K252932.
Who is the listed applicant for Fast PCR Mini Respiratory Panel?
The FDA 510(k) record lists Autonomous Medical Devices Incorporated as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Fast PCR Mini Respiratory Panel?
The FDA product code for Fast PCR Mini Respiratory Panel is QOF.
相关临床试验
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相关器械（代码：QOF）
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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