510(k) Report

Devices descending from K842280

18 later devices reach TDX Digitoxin through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K972250Roche Cobas Integra Reagent Cassettes & Ancillary ReagentsRoche Diagnostic Systems, Inc.1997171
+2K132031Afinion Lipid Panel and Afinion Lipid Panel ControlAxis-Shield Poc AS20140—
+2K111753Hitachi Clinical Analyzer S Test Reagent Catridge for: Cholestrol, HDL, LDL, and…Hitachi Chemical Diagnostics, Inc.20110—
+2K062239Glucose HK New Formulation Test SystemRoche Diagnostics Corp.20060—
+2K061048Cobas Integra Glucose HK Gen. 3 Test SystemRoche Diagnostics Corp.20061—
+2K031856Preciset TDM I and Preciset TDM II CalibratorsRoche Diagnostics Corp.200312
+2K980996Cobas Integra Carbon Dioxide (CO2-S), Cobas Integra Glucose HK Liquid (Glulf)Roche Diagnostic Systems, Inc.19989—
+3K092603Cobas Integra Glucose HK Gen 3 AssayRoche Diagnostics20090—
+3K091617QMS Lidocaine Calibrators, Model 0374678Thermo Fisher Scientific20090—
+3K031879Cobas Integra Carbon Dioxide AssayRoche Diagnostics Corp.20038—
+4K183555GEM Premier ChemSTATInstrumentation Laboratory CO20191—
+4K111960Elitech Clinical Systems Carbon Dioxide Electrode, Elitech Clinical Systems Ise…Elitechgroup20110—
+4K060205General Chemistries on Abx Pentra 400 Clinical Chemistry AnalyzerHoriba Abx200612
+4K032377Roche Diagnostics Hitachi Bicarbonate LiquidRoche Diagnostics Corp.20032—
+5K223090GEM Premier ChemSTATInstrumentation Laboratory CO20230—
+5K100263Elitech Clinical Systems Phosphorus, Uric Acid Mono SL and Urea UV SL ReagentsSeppim S.A.S.20110—
+5K071340Carbon Dioxide (CO2), Scal, Nortrol and AbtrolThermofisher Scientific OY20070—
+5K060295Carbon DioxideAbbott Laboratories200601