510(k) Report

Devices descending from K840880

19 later devices reach Ektachem Clinical Chem. Slides through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182063VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS…Ortho-Clinical Diagnostics, Inc.2018120
+1K040174Bilirubin Assay on the Omni S AnalyzerRoche Diagnostics Corp.20040—
+1K991417Abl 735 AnalyzerRadiometer America, Inc.1999162
+2K190326VITROS XT Chemistry Products UREA-CREA SlidesOrtho-Clinical Diagnostics, Inc.20190—
+2K093623Gem Premier 4000 with Iqm (Addition of Total Bilirubin Parameter), Gem CVP 2 (Addition…Instrumentation Laboratory CO2010125
+2K073537Neonatal Bilirubin on Rapidlab Models 1245 and 1265Siemens Medical Solutions Diagnostics200817
+3K160225GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized Calcium), GEM…Instrumentation Laboratory CO20162—
+3K112995Gem Premier 4000Instrumentation Laboratory CO201211—
+3K110277Rapidpoint 405 Neonatal BilirubinSiemens Healthcare Diagnostics201105
+4K203790GEM Premier 5000Instrumentation Laboratory CO2021125
+4K133407Gem Premier 4000Instrumentation Laboratory CO201410—
+5K223608GEM Premier 7000 with IQM3Instrumentation Laboratory Company202302
+5K183549GEM Premier ChemSTATInstrumentation Laboratory CO20191—
+5K183546GEM Premier ChemSTATInstrumentation Laboratory CO20191—
+5K173403GEM Premier 5000Instrumentation Laboratory CO20172—
+5K160415GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin…Instrumentation Laboratory CO20162—
+5K160412GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2)Instrumentation Laboratory CO201601
+5K160402GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin)Instrumentation Laboratory CO20162—
+6K223090GEM Premier ChemSTATInstrumentation Laboratory CO20230—