510(k) Report

Devices descending from K891475

17 later devices reach Lyphochek (R) Immunoassay Contr Serum (Human) 1,2,3 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K060205General Chemistries on Abx Pentra 400 Clinical Chemistry AnalyzerHoriba Abx200612
+1K981864Access Afp QC on the Access Immunoassay Analyzer, Model Number 33219Beckman Coulter, Inc.199811
+1K981532Lyphochek Immunoassay Plus ControlBio-Rad199812—
+2K121603Randox Immunoassay Speciality Control (II), Level 1, Level 2 and Level 3Randox Laboratories, Ltd.20120—
+2K110616Thermo Scientific Mas Omni-Immune, Mas Omni Immune ProMicrogenics Corp.201103
+2K100263Elitech Clinical Systems Phosphorus, Uric Acid Mono SL and Urea UV SL ReagentsSeppim S.A.S.20110—
+2K050536Quest Diagnostics Immunoassay/TDM ControlBio-Rad20050—
+2K043108Liquichek Specialty Immunoassay ControlBio-Rad Laboratories, Inc.20045—
+2K994277Access Ostase QCBeckman Coulter, Inc.200002
+2K990016Vitros Immunodiagnostic Products Anemia ControlsOrtho-Clinical Diagnostics, Inc.19990—
+2K984594Lyphochek Maternal Serum Control, Model 220Bio-Rad19991—
+3K143379Liquichek Maternal Serum II ControlBio-Rad Laboratories20150—
+3K133960Lypochek Specialty Immunoassay ControlBio-Rad Laboratories20140—
+3K130337Randox Speciality Control (I) Levels 1, 2 and 3Randox Laboratories Limited20130—
+3K110641Fujirebio Diagnostics Vitamin D ControlFujirebio Diagnostics,Inc.20111—
+3K092749Mas and Mini-Trol PTH ControlMicrogenics Corporation20090—
+4K113177Complete D 25-OH Vitamin D ControlQuantimetrix Corp.20120—