510(k) Report

Devices descending from K981532

12 later devices reach Lyphochek Immunoassay Plus Control through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121603Randox Immunoassay Speciality Control (II), Level 1, Level 2 and Level 3Randox Laboratories, Ltd.20120—
+1K110616Thermo Scientific Mas Omni-Immune, Mas Omni Immune ProMicrogenics Corp.201103
+1K050536Quest Diagnostics Immunoassay/TDM ControlBio-Rad20050—
+1K043108Liquichek Specialty Immunoassay ControlBio-Rad Laboratories, Inc.20045—
+1K990016Vitros Immunodiagnostic Products Anemia ControlsOrtho-Clinical Diagnostics, Inc.19990—
+1K984594Lyphochek Maternal Serum Control, Model 220Bio-Rad19991—
+2K143379Liquichek Maternal Serum II ControlBio-Rad Laboratories20150—
+2K133960Lypochek Specialty Immunoassay ControlBio-Rad Laboratories20140—
+2K130337Randox Speciality Control (I) Levels 1, 2 and 3Randox Laboratories Limited20130—
+2K110641Fujirebio Diagnostics Vitamin D ControlFujirebio Diagnostics,Inc.20111—
+2K092749Mas and Mini-Trol PTH ControlMicrogenics Corporation20090—
+3K113177Complete D 25-OH Vitamin D ControlQuantimetrix Corp.20120—