510(k) Report

Devices descending from K801297

16 later devices reach Cobas Reagent for Glucose Rapid through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K052007Abx Pentra 400 Clinical Chemistry Analyzer (Option: I.S.E. Module)Horiba Abx2005156
+2K123171Abx Pentra Calcium as CP, Abx Pentra Urine Control L/H, Abx Pentra Multical, Abx Pentra…Horiba Abx Sas20132—
+2K110530Abx Pentra Creatinine 120 CP; Abx Pentra Multical; Abx Pentra N Control; Abx Pentra P…Horiba Abx Sas201213
+2K103788Pentra C200, Ise Module and Abx Pentra Glucose HK CP ReagentHoriba Abx Sas201101
+2K110137Abx Pentra Enzymatic Creatinine CP, Abx Pentra Multical, Abx Pentra N Control, Abx…Horiba Abx Sas201112
+2K102647Elitech Clinical Systems Selectra Prom/Elical 2/Elitrol I and Elitrol II/Ast/Got 4+1…Elitechgroup Vital Scientific BV201104
+2K100525Elitech Clinical Systems Glucose Pap SL Elitech Clinical Systems Elical 2, Elitech…Seppim S.A.S.201004
+2K072115Abx Pentra Creatinine 120 CP, Total Protein 100 CP, Multical, N and P Controls, and…Horiba Abx200701
+2K062180Abx Pentra Amylase CP; Multical; N Control; P Control; Clean-Chem CP; Clean-Chem 99 CPHoriba Abx20060—
+2K060854Abx Pentra 400: LipoproteinsHoriba Abx200632
+3K193649Yumizen C1200 Creatinine PAPHoriba Abx Sas20210—
+3K191396Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine JaffeHoriba Abx Sas20190—
+3K151113ELITech Clinical Systems CALCIUM ARSENAZOElitechgroup20150—
+3K103747Elitech Clincal Systems Cholesterol HDL SL 2G, HDL 2G Calibrator, LDL SL 2G, LDL 2G…Elitechgroup Seppim S.A.S.20110—
+3K102993Elitech Clinical Systems Triglycerides SL, Elitech Clinical Systems Cholesterol SLSeppim S.A.S.20110—
+3K062737Cardiac Markers on Abx Pentra 400 Clinical Chemistry AnalyzerHoriba Abx20070—