510(k) Report

Devices descending from K112725

8 later devices reach Liaison 25 OH Vitamin D Total Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191499MAGLUMI 2000 25-OH Vitamin DShenzhen New Industries Biomedical Engineering Co., Ltd.20191—
+1K142373Access 25(OH) Vitamin D Total for Use on the Access 2 Immuno. Syst., Access 25(OH)…Beckman Coulter, Inc.20141—
+1K142362Access 25(OH) Vitamin D Total for Use on the UniCel Dxl Immuno. Syst. Access 25(OH)…Beckman Coulter, Inc.20140—
+1K133410Diazyme 25-OH Vitamin D Assay; Diazyme 25-OH Vitamin D Control SetDiazyme Laboratories20140—
+1K132492Liaison 25 Total-DDiaSorin, Inc.20130—
+1K123983Fastpack Vitamin D; Immunoassay, Calibrators, Controls, VerifiersQualigen, Inc.201302
+2K232587MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzerShenzhen New Industries Biomedical Engineering Co., Ltd.20240—
+2K223503Access 25(OH) Vitamin D TotalBeckman Coulter, Inc.20230—