510(k) Report

Devices descending from K061575

5 later devices reach Olympus Calcium Arsenazo Reagent, OSR60117, OSR61117, OSR65117 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200898Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon…Medicon Hellas S.A20211—
+1K123171Abx Pentra Calcium as CP, Abx Pentra Urine Control L/H, Abx Pentra Multical, Abx Pentra…Horiba Abx Sas20132—
+2K251157Core MetabolicTruvian Health20260—
+2K191396Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine JaffeHoriba Abx Sas20190—
+2K151113ELITech Clinical Systems CALCIUM ARSENAZOElitechgroup20150—