FDA 510(k)

세피드 업스페트 C. difficile/에피 컨트롤 패널

K-번호: K190463 · 2019-04-19

결정일2019-04-19

제품 코드PMN

자문 위원회미 (Original text: MI)

결정대체적으로 동일

기기 요약

Cepheid Xpert C. difficile/Epi Control Panel is the device name listed in this FDA 510(k) record. The listed applicant is Microbiologics, Inc.. It received FDA 510(k) clearance on 2019-04-19 under 510(k) number K190463. The device is classified under product code PMN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Cepheid Xpert C. difficile/Epi Control Panel?

Cepheid Xpert C. difficile/Epi Control Panel is a medical device that received FDA 510(k) clearance on 2019-04-19. The listed applicant is Microbiologics, Inc.. The 510(k) number is K190463.

When did Cepheid Xpert C. difficile/Epi Control Panel receive FDA 510(k) clearance?

Cepheid Xpert C. difficile/Epi Control Panel received FDA 510(k) clearance on 2019-04-19, under 510(k) number K190463.

Who is the listed applicant for Cepheid Xpert C. difficile/Epi Control Panel?

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

What is the FDA product code for Cepheid Xpert C. difficile/Epi Control Panel?

The FDA product code for Cepheid Xpert C. difficile/Epi Control Panel is PMN.

Microbiologics, Inc.를 신청인으로 등재한 기타 기록

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