510(k) Report

Devices descending from K070383

2 later devices reach Enzymatic Creatinine Assay (265 Series) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110137Abx Pentra Enzymatic Creatinine CP, Abx Pentra Multical, Abx Pentra N Control, Abx…Horiba Abx Sas201112
+2K193649Yumizen C1200 Creatinine PAPHoriba Abx Sas20210—