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FDA 510(k)

BD Respiratory Viral Panel for BD MAX™ System; BD Respiratory Viral Panel-SCV2 for BD MAX™ System

Número K: K230956 · 2023-07-31

RequerenteBd Integrated Diagnostic Solutions /
Data da decisão2023-07-31
Código do produtoQOF
Comité consultivoMI
DecisãoSubstantially Equivalent

Resumo do dispositivo

BD Respiratory Viral Panel for BD MAX™ System; BD Respiratory Viral Panel-SCV2 for BD MAX™ System is the device name listed in this FDA 510(k) record. The listed applicant is Bd Integrated Diagnostic Solutions /. It received FDA 510(k) clearance on 2023-07-31 under 510(k) number K230956. The device is classified under product code QOF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the BD Respiratory Viral Panel for BD MAX™ System; BD Respiratory Viral Panel-SCV2 for BD MAX™ System?

BD Respiratory Viral Panel for BD MAX™ System; BD Respiratory Viral Panel-SCV2 for BD MAX™ System is a medical device that received FDA 510(k) clearance on 2023-07-31. The listed applicant is Bd Integrated Diagnostic Solutions /. The 510(k) number is K230956.

When did BD Respiratory Viral Panel for BD MAX™ System; BD Respiratory Viral Panel-SCV2 for BD MAX™ System receive FDA 510(k) clearance?

BD Respiratory Viral Panel for BD MAX™ System; BD Respiratory Viral Panel-SCV2 for BD MAX™ System received FDA 510(k) clearance on 2023-07-31, under 510(k) number K230956.

Who is the listed applicant for BD Respiratory Viral Panel for BD MAX™ System; BD Respiratory Viral Panel-SCV2 for BD MAX™ System?

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

What is the FDA product code for BD Respiratory Viral Panel for BD MAX™ System; BD Respiratory Viral Panel-SCV2 for BD MAX™ System?

The FDA product code for BD Respiratory Viral Panel for BD MAX™ System; BD Respiratory Viral Panel-SCV2 for BD MAX™ System is QOF.

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