Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MAGLUMI 2000 25-OH Vitamin D

K-Number: K191499 · 2019-08-01

ApplicantShenzhen New Industries Biomedical Engineering Co., Ltd.
Decision Date2019-08-01
Product CodeMRG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MAGLUMI 2000 25-OH Vitamin D is a medical device manufactured by Shenzhen New Industries Biomedical Engineering Co., Ltd.. It received FDA 510(k) clearance on 2019-08-01 under approval number K191499. 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 2000 25-OH Vitamin D?

MAGLUMI 2000 25-OH Vitamin D is a medical device that received FDA 510(k) clearance on 2019-08-01. It is manufactured by Shenzhen New Industries Biomedical Engineering Co., Ltd.. The 510(k) number is K191499.

When was MAGLUMI 2000 25-OH Vitamin D approved by the FDA?

MAGLUMI 2000 25-OH Vitamin D received FDA 510(k) clearance on 2019-08-01, under approval number K191499.

What company makes MAGLUMI 2000 25-OH Vitamin D?

MAGLUMI 2000 25-OH Vitamin D is manufactured by Shenzhen New Industries Biomedical Engineering Co., Ltd..

What is the FDA product code for MAGLUMI 2000 25-OH Vitamin D?

The FDA product code for MAGLUMI 2000 25-OH Vitamin D is MRG.

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

K162698MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer K182423MAGLUMI 2000 FT4 K192547MAGLUMI 2000 HCG/ß-HCG K232587MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer

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.

↑