FDA 510(k)

BD CTGCTV2

Número K: K243343 · 2025-04-22

RequerenteBd Integrated Diagnostic Solutions/Becton,

Data da decisão2025-04-22

Código do produtoQEP

Comité consultivoMI

DecisãoSubstantially Equivalent

Resumo do dispositivo

BD CTGCTV2 is the device name listed in this FDA 510(k) record. The listed applicant is Bd Integrated Diagnostic Solutions/Becton,. It received FDA 510(k) clearance on 2025-04-22 under 510(k) number K243343. The device is classified under product code QEP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the BD CTGCTV2?

BD CTGCTV2 is a medical device that received FDA 510(k) clearance on 2025-04-22. The listed applicant is Bd Integrated Diagnostic Solutions/Becton,. The 510(k) number is K243343.

When did BD CTGCTV2 receive FDA 510(k) clearance?

BD CTGCTV2 received FDA 510(k) clearance on 2025-04-22, under 510(k) number K243343.

Who is the listed applicant for BD CTGCTV2?

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

What is the FDA product code for BD CTGCTV2?

The FDA product code for BD CTGCTV2 is QEP.

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