510(k) Report

Devices descending from K033501

31 later devices reach Modification to Calibrator for Automatic Systems (Cfas) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153644ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech…Elitechgroup20160—
+1K151552ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical…Elitechgroup20150—
+1K132399Elitech Clinical Systems Creatinine Pap SL, Elical 2, Elitrol I and Elitrol II, Urine…Elitechgroup20140—
+1K130765Elitech Clinical Systems Elical 2; Elitech Clinical Systems Elitrol I, Elitech Clinical…Elitechgroup20130—
+1K122858Eltech Chinical System Amylase SL Elitech Clinical Systems ELICAL2 Eltech Clinical…Elitechgroup20120—
+1K122083Elitech Clinical Systems CK Nac SLElitechgroup20121—
+1K103376Elitech Clinical Systems Creatinne Pap SL Model CRSL-0250, Clitech Clinical Systems…Seppim S.A.S.20110—
+1K110780Elitech Clinical Systems Bilirubin Total 4+1, Elitech Clinical Systems Elical 2, Elitech…Elitechgroup20110—
+1K112029Elitech Clinical Systems Elical 2, Elitech Clinical Systems Elitrol I, Elitech Clinical…Elitechgroup20110—
+1K110830Elitech Clinical Systems Calcium Arsenazo; Elitech Clinical Systems Albumin; Elitech…Elitechgroup201101
+1K102993Elitech Clinical Systems Triglycerides SL, Elitech Clinical Systems Cholesterol SLSeppim S.A.S.20110—
+1K100263Elitech Clinical Systems Phosphorus, Uric Acid Mono SL and Urea UV SL ReagentsSeppim S.A.S.20110—
+1K102647Elitech Clinical Systems Selectra Prom/Elical 2/Elitrol I and Elitrol II/Ast/Got 4+1…Elitechgroup Vital Scientific BV201104
+1K100525Elitech Clinical Systems Glucose Pap SL Elitech Clinical Systems Elical 2, Elitech…Seppim S.A.S.201004
+1K093883Ast/Got 4+1 SL, Ast/Got 4+1 SL, Elical 2, Elitrol I, Elitrol II, Model Assl-0250…Seppim S.A.S.20100—
+1K062319Calibrator for Automated Systems (C.F.a.S.), Model 10759350 360Roche Diagnostics Corp.20061—
+1K052007Abx Pentra 400 Clinical Chemistry Analyzer (Option: I.S.E. Module)Horiba Abx2005156
+2K141265Elitech Clinical Systems Envoy 500 CK Reagent KitElitechgroup20140—
+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
+2K101456Roche Diagnostics Calibrator for Automated Systems, Roche Diagnostics Calibrator…Roche Diagnostics20100—
+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—
+3K062737Cardiac Markers on Abx Pentra 400 Clinical Chemistry AnalyzerHoriba Abx20070—