510(k) Report

Devices descending from K950164

4 later devices reach Piccolo (TM) Primary Health Panel Reagent Rotor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251157Core MetabolicTruvian Health20260—
+1K171971Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical…Lite-On Technology Corp. H.S.P.B.20182—
+2K251074Tru Liver Health Test PanelTruvian Health20250—
+2K251058Tru Kidney Health Test Panel; Tru AnalyzerTruvian Health20250—