FDA 510(k)

엔터릭바이오 Dx 검사

K-번호: K182703 · 2019-06-19

결정일2019-06-19

제품 코드PCH

자문 위원회미 (Original text: MI)

결정대체적으로 동일

기기 요약

EntericBio Dx Assay is the device name listed in this FDA 510(k) record. The listed applicant is Serosep , Ltd.. It received FDA 510(k) clearance on 2019-06-19 under 510(k) number K182703. The device is classified under product code PCH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the EntericBio Dx Assay?

EntericBio Dx Assay is a medical device that received FDA 510(k) clearance on 2019-06-19. The listed applicant is Serosep , Ltd.. The 510(k) number is K182703.

When did EntericBio Dx Assay receive FDA 510(k) clearance?

EntericBio Dx Assay received FDA 510(k) clearance on 2019-06-19, under 510(k) number K182703.

Who is the listed applicant for EntericBio Dx Assay?

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

What is the FDA product code for EntericBio Dx Assay?

The FDA product code for EntericBio Dx Assay is PCH.

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FDA 데이터베이스에서 보기 →

FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.

엔터릭바이오 Dx 검사

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: PCH)

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