FDA 510(k)

BD MAX 자궁내막판

K-번호: K191957 · 2019-10-21

신청자Geneohm Sciences Canada, Inc. (Bd Diagnostics)

결정일2019-10-21

제품 코드PQA

자문 위원회미 (Original text: MI)

결정대체적으로 동일

기기 요약

BD MAX Vaginal Panel is the device name listed in this FDA 510(k) record. The listed applicant is Geneohm Sciences Canada, Inc. (Bd Diagnostics). It received FDA 510(k) clearance on 2019-10-21 under 510(k) number K191957. The device is classified under product code PQA. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the BD MAX Vaginal Panel?

BD MAX Vaginal Panel is a medical device that received FDA 510(k) clearance on 2019-10-21. The listed applicant is Geneohm Sciences Canada, Inc. (Bd Diagnostics). The 510(k) number is K191957.

When did BD MAX Vaginal Panel receive FDA 510(k) clearance?

BD MAX Vaginal Panel received FDA 510(k) clearance on 2019-10-21, under 510(k) number K191957.

Who is the listed applicant for BD MAX Vaginal Panel?

The FDA 510(k) record lists Geneohm Sciences Canada, Inc. (Bd Diagnostics) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BD MAX Vaginal Panel?

The FDA product code for BD MAX Vaginal Panel is PQA.

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BD MAX 자궁내막판

기기 요약

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관련 임상시험

관련 기기 (코드: PQA)

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