MRG · Class II · 21 CFR 862.1825

FDA Product Code MRG: System, Test, Vitamin D

Leading manufacturers include DiaSorin, Inc., Diazyme Laboratories and Siemens Healthcare Diagnostics, Inc..

46
Total
46
Cleared
182d
Avg days
1996
Since
Declining activity - 0 submissions in the last 2 years vs 3 in the prior period

FDA 510(k) Cleared System, Test, Vitamin D Devices (Product Code MRG)

46 devices
1–24 of 46
Cleared Apr 12, 2024
MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer
K232587
Shenzhen New Industries Biomedical Engineering Co., Ltd.
Chemistry · 231d
Cleared Sep 22, 2023
ALFIS Vitamin D, ALFIS-3 Analyzer
K221817
Immunostics Inc.,
Chemistry · 457d
Cleared Jan 19, 2023
Access 25(OH) Vitamin D Total
K223503
Beckman Coulter, Inc.
Chemistry · 58d
Cleared Sep 01, 2021
Elecsys Vitamin D total III
K210901
Roche Diagnostics
Chemistry · 159d
Cleared May 29, 2020
ADVIA Centaur Vitamin D Total (VitD)
K200509
Siemens Healthcare Diagnostics, Inc.
Chemistry · 88d
Cleared Aug 01, 2019
MAGLUMI 2000 25-OH Vitamin D
K191499
Shenzhen New Industries Biomedical Engineering Co., Ltd.
Chemistry · 56d
Cleared Jun 22, 2018
BioPlex 2200 25-OH Vitamin D Kit
K180577
Bio-Rad Laboratories
Chemistry · 109d
Cleared Jan 11, 2018
Diazyme EZ Vitamin D Assay
K172992
Diazyme Laboratories
Chemistry · 106d
Cleared Mar 16, 2017
LOCI Total Vitamin D Total Assay, LOCI VITD CAL
K162298
Siemens Healthcare Diagnostics
Chemistry · 212d
Cleared Feb 08, 2017
Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II, Vitamin D CalCheck 5
K162840
Roche Diagnostics
Chemistry · 120d
Cleared Aug 12, 2016
ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P02 Calibrators, ARCHITECT 25-OH Vitamin D 5P02 Controls
K153375
Abbott Laboratories
Chemistry · 263d
Cleared Apr 15, 2016
Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators
K153361
Fujirebio Diagnostics,Inc.
Chemistry · 147d
Cleared Jan 09, 2015
BIOPLEX(R) 2200 25-OH VITAMIN D KIT, BIOPLEX(R) 2200 25-OH VITAMIN D CALIBRATOR SET, AND BIOPLEX(R) 2200 25-OH VITAMIN D
K141114
Bio-Rad Laboratories
Chemistry · 254d
Cleared Dec 22, 2014
Access 25(OH) Vitamin D Total for Use on the Access 2 Immuno. Syst., Access 25(OH) Vitamin D Total Calibrators for Use on the Access 2 Immuno. Syst
K142373
Beckman Coulter, Inc.
Chemistry · 119d
Cleared Dec 19, 2014
Access 25(OH) Vitamin D Total for Use on the UniCel Dxl Immuno. Syst. Access 25(OH) Vitamin D Total Calibrators for Use on the UniCel Dxl Immuno.
K142362
Beckman Coulter, Inc.
Chemistry · 116d
Cleared Dec 10, 2014
LIASON XL1,25 DIHYDROXYVITAMIN D
K141463
DiaSorin, Inc.
Chemistry · 190d
Cleared Jul 24, 2014
ADVIA CENTAUR VITAMIN D TOTAL (VITD) ASSAY
K133156
Siemens Healthcare Diagnostics, Inc.
Chemistry · 280d
Cleared Mar 14, 2014
DIAZYME 25-OH VITAMIN D ASSAY
K133410
Diazyme Laboratories
Chemistry · 127d
Cleared Sep 05, 2013
LIAISON 25 TOTAL-D
K132492
DiaSorin, Inc.
Chemistry · 27d
Cleared Feb 15, 2013
VITROS IMMUNODIAGNOSTIC PRODUCTS 25-OH VITAMIN D TOTAL REAGENT PACK, VITAMIN D TOTAL CALIBRATORS
K121608
Ortho-Clinical Diagnostics, Inc.
Chemistry · 259d
Cleared Nov 28, 2012
DIAZYME 25-HYDROXY VITAMIN D EIA KIT DIAZYME 25-HYDROXY VITAMIN D EIA CONTROL SET DIA
K122420
Diazyme Laboratories
Chemistry · 111d
Cleared Jul 24, 2012
ELECSYS VITAMIN D ASSAY ELECSYS VITAMIN D CALSET ELECSYS PRECICONTROL VARIA 3 ELECSYS VITAMIN D CALCHECK 5
K113546
Roche Diagnostics
Chemistry · 236d
Cleared Jan 20, 2012
LIAISON 25 OH VITAMIN D TOTAL ASSAY
K112725
DiaSorin, Inc.
Chemistry · 122d
Cleared Oct 14, 2011
ADVIA CENTAUR VITAMIN D TOTAL ASSAY
K110586
Siemens Healthcare Diagnostics, Inc.
Chemistry · 227d

About Product Code MRG - Regulatory Context

510(k) Submission Activity

46 total 510(k) submissions under product code MRG since 1996, with 46 receiving FDA clearance (average review time: 182 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 3 in the prior period.