510(k) Report

Devices descending from K971477

6 later devices reach Urea (Urea Nitrogen) - Incorporating Dynamic Stabilization Technology (DST) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070146Abx Pentra Glucose HK CP, Urea CP, Uric Acid CPHoriba Abx20073—
+1K992800Sigma Diagnostics Infinity Bun Reagent, Models 63-25, 63-100P, 63-500P, 63-2000P, 64-20…Sigma Diagnostics, Inc.19990—
+1K982236Sigma Diagnostics Infinity Bun Reagent KitSigma Diagnostics, Inc.19980—
+2K100263Elitech Clinical Systems Phosphorus, Uric Acid Mono SL and Urea UV SL ReagentsSeppim S.A.S.20110—
+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—