FDA 510(k) Applications for Medical Device Product Code "QQY"

FDA 510(k) Number Applicant Device Name Decision Date
K213280 BD Kiestra B.V. BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD Kiestra MRSA App 05/04/2023
K200839 Clever Culture Systems APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence with IC Chromogenic MRSA TFS/S Analysis Module 10/28/2021


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