FDA 510(k)

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

K-Nummer: K214122 · 2022-07-28

AntragstellerBecton, Dickinson and Company

Entscheidungsdatum2022-07-28

ProduktcodePCI

BeratungsausschussMI

EntscheidungSubstantially Equivalent

Produktübersicht

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.

Häufig gestellte Fragen

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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Verwandte Geräte (Code: PCI)

K250358BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus for BD COR System, and Enteric Bacterial Panel Diluent for BD COR SystemBecton, Dickinson and Company K173330PanNAT STEC TestMicronics, Inc.K163571Great Basin Stool Bacterial Pathogens PanelGreat Basin Scientific, Inc.

Offizielle Quelle

In der FDA-Datenbank anzeigen →

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