510(k) Report

Devices descending from K954000

6 later devices reach Roche Reagent for Bun through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K183555GEM Premier ChemSTATInstrumentation Laboratory CO20191—
+1K103615Ace Urea Nitrogen Reagent, Calcium-Arseazo Reagent, Creatinine Reagent, Inorganic…Alfa Wassermann Diagnostic Technologies, Inc.201101
+1K060205General Chemistries on Abx Pentra 400 Clinical Chemistry AnalyzerHoriba Abx200612
+1K981123UREATrace Scientific, Ltd.19980—
+2K223090GEM Premier ChemSTATInstrumentation Laboratory CO20230—
+2K100263Elitech Clinical Systems Phosphorus, Uric Acid Mono SL and Urea UV SL ReagentsSeppim S.A.S.20110—