510(k) Report

Devices descending from K183648

3 later devices reach APAS Independence with Urine Analysis Module through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251511PhenoMATRIXCopan Wasp Srl20260—
+1K200839APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence with IC…Clever Culture Systems20212—
+2K213280BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD Kiestra…Bd Kiestra B.V.20230—