510(k) Report

Devices descending from K990460

43 later devices reach Calibrator for Automated Systems (C.F.a.S.) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080485Aspartate Amino Transferase (Ast/Sgot) Test System, Asat (Got) FSDiasys Diagnostics Systems GmbH20080—
+1K081731Dimension Cki Flex Reagent Cartridge, Dimension Mbi Flex Reagent Cartridge, and Cki/Mbi…Siemens Healthcare Diagnostics200831
+1K033643CO2 Calibrator/DiluentBayer Healthcare, Diagnostics Division20040—
+1K033501Modification to Calibrator for Automatic Systems (Cfas)Roche Diagnostics Corp.200331—
+1K030169Setpoint Chemistry CalibratorBayer Healthcare, LLC20034—
+2K153644ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech…Elitechgroup20160—
+2K151552ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical…Elitechgroup20150—
+2K132399Elitech Clinical Systems Creatinine Pap SL, Elical 2, Elitrol I and Elitrol II, Urine…Elitechgroup20140—
+2K130765Elitech Clinical Systems Elical 2; Elitech Clinical Systems Elitrol I, Elitech Clinical…Elitechgroup20130—
+2K122858Eltech Chinical System Amylase SL Elitech Clinical Systems ELICAL2 Eltech Clinical…Elitechgroup20120—
+2K122083Elitech Clinical Systems CK Nac SLElitechgroup20121—
+2K103376Elitech Clinical Systems Creatinne Pap SL Model CRSL-0250, Clitech Clinical Systems…Seppim S.A.S.20110—
+2K110780Elitech Clinical Systems Bilirubin Total 4+1, Elitech Clinical Systems Elical 2, Elitech…Elitechgroup20110—
+2K112029Elitech Clinical Systems Elical 2, Elitech Clinical Systems Elitrol I, Elitech Clinical…Elitechgroup20110—
+2K110830Elitech Clinical Systems Calcium Arsenazo; Elitech Clinical Systems Albumin; Elitech…Elitechgroup201101
+2K102993Elitech Clinical Systems Triglycerides SL, Elitech Clinical Systems Cholesterol SLSeppim S.A.S.20110—
+2K100263Elitech Clinical Systems Phosphorus, Uric Acid Mono SL and Urea UV SL ReagentsSeppim S.A.S.20110—
+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
+2K093883Ast/Got 4+1 SL, Ast/Got 4+1 SL, Elical 2, Elitrol I, Elitrol II, Model Assl-0250…Seppim S.A.S.20100—
+2K083465Dimension Vista Creatine Kinase Flex Reagent Cartridge and Dimension Vista Creatine…Siemens Healthcare Diagnostics200901
+2K083579Dimension Vista System Enzyme 6 Calibrator, Model KC360Siemens Healthcare Diagnostics20091—
+2K062319Calibrator for Automated Systems (C.F.a.S.), Model 10759350 360Roche Diagnostics Corp.20061—
+2K052007Abx Pentra 400 Clinical Chemistry Analyzer (Option: I.S.E. Module)Horiba Abx2005156
+2K031683Tox Ammonia CalibratorBayer Healthcare, LLC200301
+2K031682Lipoprotein CalibratorBayer Healthcare, LLC20032—
+3K160724ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 CalibratorSiemens Healthcare Diagnostics, Inc.201602
+3K141265Elitech Clinical Systems Envoy 500 CK Reagent KitElitechgroup20140—
+3K123171Abx Pentra Calcium as CP, Abx Pentra Urine Control L/H, Abx Pentra Multical, Abx Pentra…Horiba Abx Sas20132—
+3K110530Abx Pentra Creatinine 120 CP; Abx Pentra Multical; Abx Pentra N Control; Abx Pentra P…Horiba Abx Sas201213
+3K103788Pentra C200, Ise Module and Abx Pentra Glucose HK CP ReagentHoriba Abx Sas201101
+3K110137Abx Pentra Enzymatic Creatinine CP, Abx Pentra Multical, Abx Pentra N Control, Abx…Horiba Abx Sas201112
+3K101456Roche Diagnostics Calibrator for Automated Systems, Roche Diagnostics Calibrator…Roche Diagnostics20100—
+3K072115Abx Pentra Creatinine 120 CP, Total Protein 100 CP, Multical, N and P Controls, and…Horiba Abx200701
+3K062180Abx Pentra Amylase CP; Multical; N Control; P Control; Clean-Chem CP; Clean-Chem 99 CPHoriba Abx20060—
+3K060854Abx Pentra 400: LipoproteinsHoriba Abx200632
+3K051619Lipoprotein for Multiple AnalytesBayer Healthcare, LLC20051—
+4K193649Yumizen C1200 Creatinine PAPHoriba Abx Sas20210—
+4K191396Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine JaffeHoriba Abx Sas20190—
+4K151113ELITech Clinical Systems CALCIUM ARSENAZOElitechgroup20150—
+4K103747Elitech Clincal Systems Cholesterol HDL SL 2G, HDL 2G Calibrator, LDL SL 2G, LDL 2G…Elitechgroup Seppim S.A.S.20110—
+4K062737Cardiac Markers on Abx Pentra 400 Clinical Chemistry AnalyzerHoriba Abx20070—
+4K061139Bayer Advia Ims Psa Calibrator and Advia Ims Cpsa CalibratorsBayer Healthcare, LLC20060—