FDA 510(k)

BD BACTEC™ Myco/F Lytic Culture Vials

K-번호: K222559 · 2023-03-24

결정일2023-03-24

제품 코드MDB

자문 위원회MI

결정Substantially Equivalent

기기 요약

BD BACTEC™ Myco/F Lytic Culture Vials is the device name listed in this FDA 510(k) record. The listed applicant is Becton, Dickinson and Company. It received FDA 510(k) clearance on 2023-03-24 under 510(k) number K222559. The device is classified under product code MDB. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the BD BACTEC™ Myco/F Lytic Culture Vials?

BD BACTEC™ Myco/F Lytic Culture Vials is a medical device that received FDA 510(k) clearance on 2023-03-24. The listed applicant is Becton, Dickinson and Company. The 510(k) number is K222559.

When did BD BACTEC™ Myco/F Lytic Culture Vials receive FDA 510(k) clearance?

BD BACTEC™ Myco/F Lytic Culture Vials received FDA 510(k) clearance on 2023-03-24, under 510(k) number K222559.

Who is the listed applicant for BD BACTEC™ Myco/F Lytic Culture Vials?

The FDA 510(k) record lists Becton, Dickinson and Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BD BACTEC™ Myco/F Lytic Culture Vials?

The FDA product code for BD BACTEC™ Myco/F Lytic Culture Vials is MDB.

Becton, Dickinson and Company를 신청인으로 등재한 기타 기록

K262163BD BBL Mueller Hinton II Broth (Cation-Adjusted); BD Difco Mueller Hinton Broth K260128BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes K252506BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutainer® Safety-Lok™ Blood Collection Set with Pre-Attached Holder K252378BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood Collection Tube K260184Onclarity™ Self-Collection Kit K252040BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection Tubes

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