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FDA 510(k)

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

K-Number: K232587 · 2024-04-12

ApplicantShenzhen New Industries Biomedical Engineering Co., Ltd.
Decision Date2024-04-12
Product CodeMRG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer is a medical device manufactured by Shenzhen New Industries Biomedical Engineering Co., Ltd.. It received FDA 510(k) clearance on 2024-04-12 under approval number K232587. The device is classified under product code MRG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer?

MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer is a medical device that received FDA 510(k) clearance on 2024-04-12. It is manufactured by Shenzhen New Industries Biomedical Engineering Co., Ltd.. The 510(k) number is K232587.

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

MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer received FDA 510(k) clearance on 2024-04-12, under approval number K232587.

What company makes MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer?

MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer is manufactured by Shenzhen New Industries Biomedical Engineering Co., Ltd..

What is the FDA product code for MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer?

The FDA product code for MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer is MRG.

Other Devices by Shenzhen New Industries Biomedical Engineering Co., Ltd.

K162698MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer K182423MAGLUMI 2000 FT4 K191499MAGLUMI 2000 25-OH Vitamin D K192547MAGLUMI 2000 HCG/ß-HCG

Related Devices (Code: MRG)

K161831IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control SetImmunodiagnostic Systems , Ltd. K153375ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P02 Calibrators, ARCHITECT 25-OH Vitamin D 5P02 ControlsAbbott Laboratories K153361Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D CalibratorsFujirebio Diagnostics,Inc. K162298LOCI Total Vitamin D Total Assay, LOCI VITD CALSiemens Healthcare Diagnostics K162840Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II, Vitamin D CalCheck 5Roche Diagnostics K162754FREND Vitamin D Test SystemNanoentek USA, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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