BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD Kiestra MRSA App— 510(k) K213280

Name: FDA 510(k) clearance K213280
Creator: U.S. Food and Drug Administration
Published: 2023-05-04

Substantially Equivalent

Bd Kiestra B.V.

FDA 510(k) clearance K213280 for BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD Kiestra MRSA App, Substantially Equivalent on 2023-05-04. Applicant: Bd Kiestra B.V.. Device class: 2.

Clearance details

Applicant: Bd Kiestra B.V.
Product code: Code QQY
Device class: Class 2
Regulation: 21 CFR 866.2190
Advisory panel: Microbiology
Date received: 2021-10-01
Decision date: 2023-05-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Drachten, NL

Download summary PDF View on FDA.gov ↗

Recent devices under product code QQY

view all

K200839 — APAS Independence with IC Chromogenic MRSA BD Analysis Module +1 more2021-10-28

Data sourced from openFDA. This site is unofficial and independent of the FDA.