FDA 510(k)

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K-번호: K223497 · 2023-02-17

결정일2023-02-17

제품 코드QBD

자문 위원회미 (Original text: MI)

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기기 요약

Spectrum Saliva Collection Device is the device name listed in this FDA 510(k) record. The listed applicant is Spectrum Solutions, LLC. It received FDA 510(k) clearance on 2023-02-17 under 510(k) number K223497. The device is classified under product code QBD. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Spectrum Saliva Collection Device?

Spectrum Saliva Collection Device is a medical device that received FDA 510(k) clearance on 2023-02-17. The listed applicant is Spectrum Solutions, LLC. The 510(k) number is K223497.

When did Spectrum Saliva Collection Device receive FDA 510(k) clearance?

Spectrum Saliva Collection Device received FDA 510(k) clearance on 2023-02-17, under 510(k) number K223497.

Who is the listed applicant for Spectrum Saliva Collection Device?

The FDA 510(k) record lists Spectrum Solutions, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Spectrum Saliva Collection Device?

The FDA product code for Spectrum Saliva Collection Device is QBD.

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기기 요약

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관련 임상시험

관련 기기 (코드: QBD)

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