510(k) Report

Devices descending from K161494

2 later devices reach Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242685Atellica® CH Creatinine_3 (Crea3)Siemens Healthcare Diagnostics, Inc.20241—
+2K251058Tru Kidney Health Test Panel; Tru AnalyzerTruvian Health20250—