510(k) Report

Devices descending from K980996

9 later devices reach Cobas Integra Carbon Dioxide (CO2-S), Cobas Integra Glucose HK Liquid (Glulf) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K031879Cobas Integra Carbon Dioxide AssayRoche Diagnostics Corp.20038—
+2K183555GEM Premier ChemSTATInstrumentation Laboratory CO20191—
+2K111960Elitech Clinical Systems Carbon Dioxide Electrode, Elitech Clinical Systems Ise…Elitechgroup20110—
+2K060205General Chemistries on Abx Pentra 400 Clinical Chemistry AnalyzerHoriba Abx200612
+2K032377Roche Diagnostics Hitachi Bicarbonate LiquidRoche Diagnostics Corp.20032—
+3K223090GEM Premier ChemSTATInstrumentation Laboratory CO20230—
+3K100263Elitech Clinical Systems Phosphorus, Uric Acid Mono SL and Urea UV SL ReagentsSeppim S.A.S.20110—
+3K071340Carbon Dioxide (CO2), Scal, Nortrol and AbtrolThermofisher Scientific OY20070—
+3K060295Carbon DioxideAbbott Laboratories200601