510(k) Report

Devices descending from K895905

10 later devices reach Lyphochek Whole Blood Control (Human) Levels 1,2,3 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K980871Lyphochek Whole Blood ControlBio-Rad19989—
+2K022041Lyphochek Whole Blood Control, Models 561, 562, 563Bio-Rad Laboratories, Inc.20026—
+2K984477Lyphochek Whole Blood Metals Control Levels 1,2,3, Models 527, 528, 529Bio-Rad19991—
+3K072721Lyphochek Whole Blood Immunosuppressant Control , Abbott Immunosuppressant MCCBio-Rad, Diagnostics Grp.20072—
+3K051074Mas Immunosuppressant ControlsMicrogenics Corp.20050—
+3K042324Lyphochek Elevated Immunosuppressant Control, Level 4, 5Bio-Rad20040—
+3K032842Microgenics Cyclosporine Control KitMicrogenics Corp.20030—
+3K020610Lyphochek Whole Blood Metals Control Model # 527, 528, 529Bio-Rad20020—
+4K132174Multichem WBTTechno-Path Manufacturing, Ltd.20130—
+4K080459Chromesytems Toxicology Calibrators and ControlsChromsystems Instruments & Chemicals GmbH20090—