FDA 510(k)

BD Veritor™ 신속한 인플루엔자 A+B 검출 시스템 CLIA 면제 키트

K-번호: K232434 · 2023-12-05

신청자Bd

결정일2023-12-05

제품 코드PSZ

자문 위원회MI

결정Substantially Equivalent

기기 요약

BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived Kit is the device name listed in this FDA 510(k) record. The listed applicant is Bd. It received FDA 510(k) clearance on 2023-12-05 under 510(k) number K232434. The device is classified under product code PSZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived Kit?

BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived Kit is a medical device that received FDA 510(k) clearance on 2023-12-05. The listed applicant is Bd. The 510(k) number is K232434.

When did BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived Kit receive FDA 510(k) clearance?

BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived Kit received FDA 510(k) clearance on 2023-12-05, under 510(k) number K232434.

Who is the listed applicant for BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived Kit?

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

What is the FDA product code for BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived Kit?

The FDA product code for BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived Kit is PSZ.

Bd를 신청인으로 등재한 기타 기록

K253445BD Surgiphor™ 1000mL 항균 세정 시스템 (910120)K240257Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery Kit K223016BD VeritorTM 신속한 인플루엔자 A+B 검출 시스템 CLIA 면제 키트 K221504BD Surgiphor™ 항균 세정 시스템 K180438BD Veritor 시스템, 인플루엔자 A + B 빠른 검출 CLIA 면제 키트

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