510(k) Report

Devices descending from K954992

21 later devices reach Roche Cobas Integra Reagent Cassettes through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K060586Enzyme Immunoassay, VancomycinRoche Diagnostics Corp.200612
+1K032334Roche Online TDM LidocaineRoche Diagnostics Corp.20040—
+1K991598Cobas Integra AcetaminophenRoche Diagnostics Corp.199911
+1K991597Cobas Integra Amikacin MabRoche Diagnostics Corp.19991—
+1K990594Integra Reagent Cassette for Apolipoprotein a-1Roche Diagnostics Corp.19991—
+1K980996Cobas Integra Carbon Dioxide (CO2-S), Cobas Integra Glucose HK Liquid (Glulf)Roche Diagnostic Systems, Inc.19989—
+1K964457Roche Cobas Ibtegra Reagent CassettesRoche Diagnostic Systems, Inc.199712
+2K152245ONLINE TDM Vancomycin Gen.3Roche Diagnostics Operations (Rdo)201602
+2K110726Roche Acetaminophen AssayRoche Diagnostics201101
+2K060853Online TDM TobramycinRoche Diagnostics Corp.200602
+2K032279Online TDM AmikaRoche Diagnostics Corp.20030—
+2K031879Cobas Integra Carbon Dioxide AssayRoche Diagnostics Corp.20038—
+2K013278Tina-Quant Apolipoprotein a-1 Ver.2Roche Diagnostics Corp.20010—
+3K183555GEM Premier ChemSTATInstrumentation Laboratory CO20191—
+3K111960Elitech Clinical Systems Carbon Dioxide Electrode, Elitech Clinical Systems Ise…Elitechgroup20110—
+3K060205General Chemistries on Abx Pentra 400 Clinical Chemistry AnalyzerHoriba Abx200612
+3K032377Roche Diagnostics Hitachi Bicarbonate LiquidRoche Diagnostics Corp.20032—
+4K223090GEM Premier ChemSTATInstrumentation Laboratory CO20230—
+4K100263Elitech Clinical Systems Phosphorus, Uric Acid Mono SL and Urea UV SL ReagentsSeppim S.A.S.20110—
+4K071340Carbon Dioxide (CO2), Scal, Nortrol and AbtrolThermofisher Scientific OY20070—
+4K060295Carbon DioxideAbbott Laboratories200601