FDA 510(k)

BD BACTEC FXI Culture System

Numéro K : K260213 · 2026-05-28

Date de décision2026-05-28

Code produitMDB

Comité consultatifMI

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

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Dispositifs connexes (Code : MDB)

K222559BD BACTEC™ Myco/F Lytic Culture VialsBecton, Dickinson and Company K222591BD BACTEC™ Plus Aerobic/F Culture VialsBecton, Dickinson and Company K190405BACT/ALERT MP Reagent SystembioMerieux, Inc.K183166BacT/ALERT FA Plus; BacT/ALERT PF PlusbioMerieux, Inc.K173873BD BACTEC Peds Plus/F Culture Vials Soybean-Casein Digest Broth with Resins in a Plastic VialBecton, Dickinson and Company K161816BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUObioMerieux, Inc.

Source officielle

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