510(k) Report

Devices descending from K032844

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103529Liaison XL Analyzer Model 10050DiaSorin, Inc.20112—
+1K072536Esa Biosciences Inc. Vitamin D HPLC TestEsa Biosciences, Inc.20080—
+1K071480Liaison 25 OH Vitamin D Total; Assay, Control Set and Specimen Diluent Set, Models…DiaSorin, Inc.200724—
+2K153361Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D CalibratorsFujirebio Diagnostics,Inc.20160—
+2K141116Liaison XL AnalyzerDiaSorin, Inc.20141—
+2K133410Diazyme 25-OH Vitamin D Assay; Diazyme 25-OH Vitamin D Control SetDiazyme Laboratories20140—
+2K130321Liaison Aldosterone, Liaison Aldosterone Control Set, Liaison Aldosterone Calibration…Diasorin20130—
+2K112725Liaison 25 OH Vitamin D Total AssayDiaSorin, Inc.20128—
+2K110619Architect 25-OH Vitamin D 100T, Vitamin D 500T, Vitamin D Calibrators, Vitamin D ControlsBiokit, S.A.2011111
+2K090104Liaison 25 OH Vitamin D Total Calibration Verifiers, Model: 310603DiaSorin, Inc.20092—
+3K260770LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteXDiaSorin, Inc.20260—
+3K191499MAGLUMI 2000 25-OH Vitamin DShenzhen New Industries Biomedical Engineering Co., Ltd.20191—
+3K162754FREND Vitamin D Test SystemNanoentek USA, Inc.20170—
+3K153375ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P02 Calibrators, ARCHITECT…Abbott Laboratories201601
+3K142373Access 25(OH) Vitamin D Total for Use on the Access 2 Immuno. Syst., Access 25(OH)…Beckman Coulter, Inc.20141—
+3K142362Access 25(OH) Vitamin D Total for Use on the UniCel Dxl Immuno. Syst. Access 25(OH)…Beckman Coulter, Inc.20140—
+3K132492Liaison 25 Total-DDiaSorin, Inc.20130—
+3K123983Fastpack Vitamin D; Immunoassay, Calibrators, Controls, VerifiersQualigen, Inc.201302
+3K113546Elecsys Vitamin D Assay Elecsys Vitamin D Calset Elecsys Precicontrol Varia 3 Elecsys…Roche Diagnostics20128—
+4K232587MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzerShenzhen New Industries Biomedical Engineering Co., Ltd.20240—
+4K223503Access 25(OH) Vitamin D TotalBeckman Coulter, Inc.20230—
+4K162840Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II…Roche Diagnostics201742
+4K132828Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol Varia 3Roche Diagnostics20132—
+5K252431Elecsys CalcitoninRoche Diagnostics GmbH20260—
+5K210901Elecsys Vitamin D total IIIRoche Diagnostics20211—
+5K182012ADVIA Centaur Calcitonin (CALCT) assayAxis-Shield Diagnostics Limited20180—
+5K170938CalSet IGF-1Roche Diagnostics20170—
+5K170678Beta-CrossLaps CalCheck 5Roche Diagnostics20170—
+6K221817ALFIS Vitamin D, ALFIS-3 AnalyzerImmunostics Inc.,20230—