FDA.reportPublic FDA data

510(k) K232587

Device
MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer
Applicant
Shenzhen New Industries Biomedical Engineering Co., Ltd.
510(k) number
K232587
Product code
MRG
Decision
Substantially Equivalent (SESE)
Decision date
2024-04-12
Date received
2023-08-25
Regulation
862.1825
Classification name
System, Test, Vitamin D
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Xiaoli Wang
Address
#16, Jinhui Rd., Pingshan New District Shenzhen CN 518122 518122

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MRG#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K221817ALFIS Vitamin D, ALFIS-3 AnalyzerImmunostics Inc.,2023-09-22
K223503Access 25(OH) Vitamin D TotalBeckman Coulter, Inc.2023-01-19
K210901Elecsys Vitamin D total IIIRoche Diagnostics2021-09-01
K200509ADVIA Centaur Vitamin D Total (VitD)Siemens Healthcare Diagnostics, Inc.2020-05-29
K191499MAGLUMI 2000 25-OH Vitamin DShenzhen New Industries Biomedical Engineering Co., Ltd.2019-08-01
K180577BioPlex 2200 25-OH Vitamin D KitBio-Rad Laboratories2018-06-22
K172992Diazyme EZ Vitamin D AssayDiazyme Laboratories2018-01-11
K162298LOCI Total Vitamin D Total Assay, LOCI VITD CALSiemens Healthcare Diagnostics2017-03-16
K162840Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II, Vitamin D CalCheck 5Roche Diagnostics2017-02-08
K162754FREND Vitamin D Test SystemNanoentek USA, Inc.2017-01-12
K161831IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control SetImmunodiagnostic Systems , Ltd.2016-11-15
K153375ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P02 Calibrators, ARCHITECT 25-OH Vitamin D 5P02 ControlsAbbott Laboratories2016-08-12
K153361Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D CalibratorsFujirebio Diagnostics,Inc.2016-04-15
K150270ST AIA-PACK 25-OH Vitamin D, ST AIA-PACK 25-OH Vitamin D Calibrator Set, AIA-PACK 25-OH Vitamin D Control Set, and ST AIA-PACK 25-OH Vitamin D Pretreatment SetTosoh Bioscience, Inc.2015-10-26
K14235125-Hydroxy Vitamin Ds EIAImmunodiagnostic Systems , Ltd.2015-08-25