510(k) Report

Devices descending from K171971

2 later devices reach Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251074Tru Liver Health Test PanelTruvian Health20250—
+1K251058Tru Kidney Health Test Panel; Tru AnalyzerTruvian Health20250—