510(k) Report

Devices descending from K912844

31 later devices reach Kodak Ektachem Dtii System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K083680Vitros Chemistry Products K+DT Slides: Vitros Chemistry Products DT Calibrator Kit…Ortho-Clinical Diagnostics, Inc.200921
+1K082099Vitros Chemistry Products CI-DT Slides; Vitros Chemistry Products DT Calibrator Kit…Ortho-Clinical Diagnostics, Inc.20083—
+1K020484Careside LDHCareside, Inc.20020—
+1K020486Careside GGTCareside, Inc.20020—
+1K020487Careside AltCareside, Inc.20020—
+1K020488Careside TrglycerideCareside, Inc.20020—
+1K993634Careside AnalyzerCareside, Inc.19990—
+1K992475Careside CO2, TotalCareside, Inc.19990—
+1K991717Careside MGCareside, Inc.19990—
+1K991371Careside AmmoniaCareside, Inc.19990—
+1K990439Careside CKCareside, Inc.19990—
+1K990434Careside CKMBCareside, Inc.19990—
+1K990036Careside Lytes, Careside Anallyzer Model 1000Careside, Inc.19990—
+1K990009Careside AstCareside, Inc.19990—
+1K990025Careside AmylaseCareside, Inc.19990—
+1K990024Careside Alkaline PhosphataseCareside, Inc.19990—
+1K983789Careside Calcium, OriginalCareside, Inc.19980—
+1K982118Careside AnalyzerExigent Diagnostics, Inc.19980—
+1K981899Careside HDL-CholesterolExigent Diagnostics, Inc.19980—
+1K981604Careside Uric AcidCareside, Inc.19980—
+1K981610Careside AnalyzerCareside, Inc.19980—
+1K981588Careside Total BilirubinCareside, Inc.19980—
+1K981183Careside GlucoseExigent Diagnostics, Inc.19980—
+1K980043Careside CreatinineExigent Diagnostics, Inc.19980—
+1K980056Careside AnalyzerExigent Diagnostics, Inc.19981—
+1K980057Careside BunExigent Diagnostics, Inc.19980—
+1K980042Careside Total ProteinExigent Diagnostics, Inc.19980—
+1K980041Careside AlbuminExigent Diagnostics, Inc.19980—
+1K980055Careside GlobulinExigent Diagnostics, Inc.19980—
+2K091861Vitros Chemistry Products NA + DT Slides, Model 153 2290 and DT Calibrator Kit, Model…Ortho-Clinical Diagnostics, Inc.20091—
+3K093611Vitros Chemistry Products CO2 DT Slides; Vitros Chemmistry Products DT Calibrator Kit…Ortho-Clinical Diagnostics, Inc.20100—