510(k) Report

Devices descending from K070727

4 later devices reach Advia Chemistry Enzymatic Creatinine_2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212223Atellica CH Enzymatic Creatinine_3 (ECre3)Siemens Healthcare Diagnostics, Inc.20210—
+1K161494Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)Siemens Healthcare Diagnostics, Inc.201621
+2K242685Atellica® CH Creatinine_3 (Crea3)Siemens Healthcare Diagnostics, Inc.20241—
+3K251058Tru Kidney Health Test Panel; Tru AnalyzerTruvian Health20250—