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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 the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen New Industries Biomedical Engineering Co., Ltd.. It received FDA 510(k) clearance on 2019-08-01 under 510(k) 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. The listed applicant is Shenzhen New Industries Biomedical Engineering Co., Ltd.. The 510(k) number is K191499.

When did MAGLUMI 2000 25-OH Vitamin D receive FDA 510(k) clearance?

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

Who is the listed applicant for MAGLUMI 2000 25-OH Vitamin D?

The FDA 510(k) record lists Shenzhen New Industries Biomedical Engineering Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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 records listing Shenzhen New Industries Biomedical Engineering Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232587MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzerK192547MAGLUMI 2000 HCG/ß-HCGK182423MAGLUMI 2000 FT4K162698MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer

Related Devices (Code: MRG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232587MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzerShenzhen New Industries Biomedical Engineering Co., Ltd.K221817ALFIS Vitamin D, ALFIS-3 AnalyzerImmunostics Inc.,K223503Access 25(OH) Vitamin D TotalBeckman Coulter, Inc.K210901Elecsys Vitamin D total IIIRoche DiagnosticsK200509ADVIA Centaur Vitamin D Total (VitD)Siemens Healthcare Diagnostics, Inc.K180577BioPlex 2200 25-OH Vitamin D KitBio-Rad Laboratories

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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