510(k) Report

Devices descending from K200839

2 later devices reach APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251511PhenoMATRIXCopan Wasp Srl20260—
+1K213280BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD Kiestra…Bd Kiestra B.V.20230—