FDA 510(k)

B. anthracis 실시간 PCR 검사

K-번호: K192871 · 2019-11-07

신청자Centers for Disease Control and Prevention

결정일2019-11-07

제품 코드NHT

자문 위원회MI

결정Substantially Equivalent

기기 요약

B. anthracis Real-time PCR Assay is the device name listed in this FDA 510(k) record. The listed applicant is Centers for Disease Control and Prevention. It received FDA 510(k) clearance on 2019-11-07 under 510(k) number K192871. The device is classified under product code NHT. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the B. anthracis Real-time PCR Assay?

B. anthracis Real-time PCR Assay is a medical device that received FDA 510(k) clearance on 2019-11-07. The listed applicant is Centers for Disease Control and Prevention. The 510(k) number is K192871.

When did B. anthracis Real-time PCR Assay receive FDA 510(k) clearance?

B. anthracis Real-time PCR Assay received FDA 510(k) clearance on 2019-11-07, under 510(k) number K192871.

Who is the listed applicant for B. anthracis Real-time PCR Assay?

The FDA 510(k) record lists Centers for Disease Control and Prevention as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for B. anthracis Real-time PCR Assay?

The FDA product code for B. anthracis Real-time PCR Assay is NHT.

Centers for Disease Control and Prevention를 신청인으로 등재한 기타 기록

13개 장치 모두 보기 →

공식 출처

FDA 데이터베이스에서 보기 →

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

기기 요약

자주 묻는 질문

관련 임상시험

Centers for Disease Control and Prevention를 신청인으로 등재한 기타 기록

공식 출처