510(k) Report

Devices descending from K980871

9 later devices reach Lyphochek Whole Blood Control through their predicates, nearest generation first.

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