510(k) Report

Devices descending from K081276

2 later devices reach Abx Pentra Glucose HK CP, Abx Pentra Uric Acid CP, Abx Pentra Urine Control L/H through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K183375Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride…Horiba, Ltd.20190—
+1K100263Elitech Clinical Systems Phosphorus, Uric Acid Mono SL and Urea UV SL ReagentsSeppim S.A.S.20110—