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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Culture Plate Imaging System For Qualitative Assessment Of Resistant Organisms
510(k) Number K213280
Device Name BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD Kiestra MRSA App
Applicant
Bd Kiestra B.V.
Marconilaan 6
Drachten,  NL 9207 JC
Applicant Contact Karin Brands
Correspondent
Bd Kiestra B.V.
Marconilaan 6
Drachten,  NL 9207 JC
Correspondent Contact Karin Brands
Regulation Number866.2190
Classification Product Code
QQY  
Date Received10/01/2021
Decision Date 05/04/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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