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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
BD Kiestra B.V.
Marconilaan 6
Drachten,  NL 9207 JC
Applicant Contact Karin Brands
BD Kiestra B.V.
Marconilaan 6
Drachten,  NL 9207 JC
Correspondent Contact Karin Brands
Regulation Number866.2190
Classification Product Code
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