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MRG — System, Test, Vitamin D Class II

FDA Device Classification

Classification Details

Product Code
MRG
Device Class
Class II
Regulation Number
862.1825
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K232587shenzhen new industries biomedical engineering coMAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay anaApril 12, 2024
K221817immunostics incALFIS Vitamin D, ALFIS-3 AnalyzerSeptember 22, 2023
K223503beckman coulterAccess 25(OH) Vitamin D TotalJanuary 19, 2023
K210901roche diagnosticsElecsys Vitamin D total IIISeptember 1, 2021
K200509siemens healthcare diagnosticsADVIA Centaur Vitamin D Total (VitD)May 29, 2020
K191499shenzhen new industries biomedical engineering coMAGLUMI 2000 25-OH Vitamin DAugust 1, 2019
K180577bio-rad laboratoriesBioPlex 2200 25-OH Vitamin D KitJune 22, 2018
K172992diazyme laboratoriesDiazyme EZ Vitamin D AssayJanuary 11, 2018
K162298siemens healthcare diagnosticsLOCI Total Vitamin D Total Assay, LOCI VITD CALMarch 16, 2017
K162840roche diagnosticsElecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D toFebruary 8, 2017
K162754nanoentek usaFREND Vitamin D Test SystemJanuary 12, 2017
K161831immunodiagnostic systemsIDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control SetNovember 15, 2016
K153375abbott laboratoriesARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P02 Calibrators, ARCHAugust 12, 2016
K153361fujirebio diagnosticsLumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D CalibratorsApril 15, 2016
K150270tosoh bioscienceST AIA-PACK 25-OH Vitamin D, ST AIA-PACK 25-OH Vitamin D Calibrator Set, AIA-PACOctober 26, 2015
K142351immunodiagnostic systems25-Hydroxy Vitamin Ds EIAAugust 25, 2015
K141114bio-rad laboratoriesBIOPLEX(R) 2200 25-OH VITAMIN D KIT, BIOPLEX(R) 2200 25-OH VITAMIN D CALIBRATOR January 9, 2015
K142373beckman coulterAccess 25(OH) Vitamin D Total for Use on the Access 2 Immuno. Syst., Access 25(December 22, 2014
K140554immunodiagnostic systemsIDS-ISYS 25-HYDROXY VITAMIN DS, AND IDS-ISYS 25 HYDROXY VITAMIN DS CONTROL SETDecember 19, 2014
K142362beckman coulterAccess 25(OH) Vitamin D Total for Use on the UniCel Dxl Immuno. Syst. Access 25(December 19, 2014