510(k) Report

Devices descending from K971485

5 later devices reach Uric Acid - Incorporating Dynamic Stabilization Technology - (DST) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081276Abx Pentra Glucose HK CP, Abx Pentra Uric Acid CP, Abx Pentra Urine Control L/HHoriba Abx200821
+1K992798Sigma Diagnostics Infinity Uric Acid Reagent, Models 684-25, 684-100P, 684-500P…Sigma Diagnostics, Inc.19990—
+1K982251Sigma Diagnostics Infinity Uric Acid Reagent KitSigma Diagnostics, Inc.19980—
+2K183375Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride…Horiba, Ltd.20190—
+2K100263Elitech Clinical Systems Phosphorus, Uric Acid Mono SL and Urea UV SL ReagentsSeppim S.A.S.20110—