FDA 510(k)

쿼이 코로나19 분자 검사

K-번호: K232643 · 2023-11-28

결정일2023-11-28

제품 코드QWB

자문 위원회미 (Original text: MI)

결정대체적으로 동일

기기 요약

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.

자주 묻는 질문

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.

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쿼이 코로나19 분자 검사

기기 요약

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관련 임상시험

관련 기기 (코드: QWB)

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