MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer

FDA 510(k) K232587 · Shenzhen New Industries Biomedical Engineering Co., Ltd.

Substantially Equivalent

510(k) numberK232587

Submission

Device name
MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer
Applicant
Shenzhen New Industries Biomedical Engineering Co., Ltd.
Shenzhen, CN
Received
August 25, 2023
Decision date
April 12, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MRG – System, Test, Vitamin D
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1825
Specialty
Clinical Chemistry

Other 510(k)s with product code MRG

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K221817ALFIS Vitamin D, ALFIS-3 AnalyzerMRG · Traditional Immunostics Inc.,09/22/2023SE
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K210901Elecsys Vitamin D total IIIMRG · Traditional Roche Diagnostics09/01/2021SE
K200509ADVIA Centaur Vitamin D Total (VitD)MRG · Traditional Siemens Healthcare Diagnostics, Inc.05/29/2020SE
K191499MAGLUMI 2000 25-OH Vitamin DMRG · Traditional Shenzhen New Industries Biomedical Engineering…08/01/2019SE
K180577BioPlex 2200 25-OH Vitamin D KitMRG · Traditional Bio-Rad Laboratories06/22/2018SE
K172992Diazyme EZ Vitamin D AssayMRG · Traditional Diazyme Laboratories01/11/2018SE
K162298LOCI Total Vitamin D Total Assay, LOCI VITD CALMRG · Traditional Siemens Healthcare Diagnostics03/16/2017SE
K162840Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II…MRG · Traditional Roche Diagnostics02/08/2017SE
K162754FREND Vitamin D Test SystemMRG · Traditional Nanoentek USA, Inc.01/12/2017SE

More from Nanoentek USA, Inc.

510(k)DeviceDecision
K192547MAGLUMI 2000 HCG/ß-HCGDHA · Traditional 01/17/2020SE
K191499MAGLUMI 2000 25-OH Vitamin DMRG · Traditional 08/01/2019SE
K182423Maglumi 2000 FT4CEC · Traditional 10/04/2018SE
K162698MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay AnalyzerJLW · Traditional 07/14/2017SE

Questions and answers

When was MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer cleared by the FDA?

MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer (K232587) received a 510(k) decision of Substantially Equivalent on April 12, 2024, 231 days after the submission was received.

What is the product code of K232587?

The FDA product code is MRG – System, Test, Vitamin D, a Class II (moderate risk) device regulated under 21 CFR 862.1825.