510(k) Report

Devices descending from K070249

11 later devices reach Abx Pentra 400, Calcium CP, Creatinine CP, Phosphorus CP, Amylase CP, Urine… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123171Abx Pentra Calcium as CP, Abx Pentra Urine Control L/H, Abx Pentra Multical, Abx Pentra…Horiba Abx Sas20132—
+1K110530Abx Pentra Creatinine 120 CP; Abx Pentra Multical; Abx Pentra N Control; Abx Pentra P…Horiba Abx Sas201213
+1K110137Abx Pentra Enzymatic Creatinine CP, Abx Pentra Multical, Abx Pentra N Control, Abx…Horiba Abx Sas201112
+1K100263Elitech Clinical Systems Phosphorus, Uric Acid Mono SL and Urea UV SL ReagentsSeppim S.A.S.20110—
+1K072115Abx Pentra Creatinine 120 CP, Total Protein 100 CP, Multical, N and P Controls, and…Horiba Abx200701
+1K070146Abx Pentra Glucose HK CP, Urea CP, Uric Acid CPHoriba Abx20073—
+2K193649Yumizen C1200 Creatinine PAPHoriba Abx Sas20210—
+2K191396Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine JaffeHoriba Abx Sas20190—
+2K151113ELITech Clinical Systems CALCIUM ARSENAZOElitechgroup20150—
+2K081276Abx Pentra Glucose HK CP, Abx Pentra Uric Acid CP, Abx Pentra Urine Control L/HHoriba Abx200821
+3K183375Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride…Horiba, Ltd.20190—