FDA 510(k)

Fast PCR Mini Respiratory Panel

K-번호: K252932 · 2026-06-12

신청자Autonomous Medical Devices Incorporated

결정일2026-06-12

제품 코드QOF

자문 위원회MI

결정Substantially Equivalent

기기 요약

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.

자주 묻는 질문

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.

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Fast PCR Mini Respiratory Panel

기기 요약

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관련 임상시험

관련 기기 (코드: QOF)

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