FDA 510(k)

BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel

Número K: K214122 · 2022-07-28

Data da decisão2022-07-28

Código do produtoPCI

Comité consultivoMI

DecisãoSubstantially Equivalent

Resumo do dispositivo

BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel 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 2022-07-28 under 510(k) number K214122. The device is classified under product code PCI. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel?

BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel is a medical device that received FDA 510(k) clearance on 2022-07-28. The listed applicant is Becton, Dickinson and Company. The 510(k) number is K214122.

When did BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel receive FDA 510(k) clearance?

BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel received FDA 510(k) clearance on 2022-07-28, under 510(k) number K214122.

Who is the listed applicant for BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel?

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 MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel?

The FDA product code for BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel is PCI.

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Fonte oficial

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