FDA 510(k)

BD BACTEC FXI Culture System

Número K: K260213 · 2026-05-28

Data da decisão2026-05-28

Código do produtoMDB

Comité consultivoMI

DecisãoSubstantially Equivalent

Resumo do dispositivo

BD BACTEC FXI Culture System is the device name listed in this FDA 510(k) record. The listed applicant is BD Diagnostic Systems. It received FDA 510(k) clearance on 2026-05-28 under 510(k) number K260213. The device is classified under product code MDB. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the BD BACTEC FXI Culture System?

BD BACTEC FXI Culture System is a medical device that received FDA 510(k) clearance on 2026-05-28. The listed applicant is BD Diagnostic Systems. The 510(k) number is K260213.

When did BD BACTEC FXI Culture System receive FDA 510(k) clearance?

BD BACTEC FXI Culture System received FDA 510(k) clearance on 2026-05-28, under 510(k) number K260213.

Who is the listed applicant for BD BACTEC FXI Culture System?

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

What is the FDA product code for BD BACTEC FXI Culture System?

The FDA product code for BD BACTEC FXI Culture System is MDB.

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Dispositivos Relacionados (Código: MDB)

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Fonte oficial

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