510(k) Report

Devices descending from K071480

24 later devices reach Liaison 25 OH Vitamin D Total; Assay, Control Set and Specimen Diluent Set… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153361Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D CalibratorsFujirebio Diagnostics,Inc.20160—
+1K133410Diazyme 25-OH Vitamin D Assay; Diazyme 25-OH Vitamin D Control SetDiazyme Laboratories20140—
+1K130321Liaison Aldosterone, Liaison Aldosterone Control Set, Liaison Aldosterone Calibration…Diasorin20130—
+1K112725Liaison 25 OH Vitamin D Total AssayDiaSorin, Inc.20128—
+1K110619Architect 25-OH Vitamin D 100T, Vitamin D 500T, Vitamin D Calibrators, Vitamin D ControlsBiokit, S.A.2011111
+1K090104Liaison 25 OH Vitamin D Total Calibration Verifiers, Model: 310603DiaSorin, Inc.20092—
+2K191499MAGLUMI 2000 25-OH Vitamin DShenzhen New Industries Biomedical Engineering Co., Ltd.20191—
+2K162754FREND Vitamin D Test SystemNanoentek USA, Inc.20170—
+2K153375ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P02 Calibrators, ARCHITECT…Abbott Laboratories201601
+2K142373Access 25(OH) Vitamin D Total for Use on the Access 2 Immuno. Syst., Access 25(OH)…Beckman Coulter, Inc.20141—
+2K142362Access 25(OH) Vitamin D Total for Use on the UniCel Dxl Immuno. Syst. Access 25(OH)…Beckman Coulter, Inc.20140—
+2K132492Liaison 25 Total-DDiaSorin, Inc.20130—
+2K123983Fastpack Vitamin D; Immunoassay, Calibrators, Controls, VerifiersQualigen, Inc.201302
+2K113546Elecsys Vitamin D Assay Elecsys Vitamin D Calset Elecsys Precicontrol Varia 3 Elecsys…Roche Diagnostics20128—
+3K232587MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzerShenzhen New Industries Biomedical Engineering Co., Ltd.20240—
+3K223503Access 25(OH) Vitamin D TotalBeckman Coulter, Inc.20230—
+3K162840Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II…Roche Diagnostics201742
+3K132828Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol Varia 3Roche Diagnostics20132—
+4K252431Elecsys CalcitoninRoche Diagnostics GmbH20260—
+4K210901Elecsys Vitamin D total IIIRoche Diagnostics20211—
+4K182012ADVIA Centaur Calcitonin (CALCT) assayAxis-Shield Diagnostics Limited20180—
+4K170938CalSet IGF-1Roche Diagnostics20170—
+4K170678Beta-CrossLaps CalCheck 5Roche Diagnostics20170—
+5K221817ALFIS Vitamin D, ALFIS-3 AnalyzerImmunostics Inc.,20230—