MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer— 510(k) K232587

Name: FDA 510(k) clearance K232587
Creator: U.S. Food and Drug Administration
Published: 2024-04-12

Substantially Equivalent

Shenzhen New Industries Biomedical Engineering Co., Ltd.

FDA 510(k) clearance K232587 for MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer, Substantially Equivalent on 2024-04-12. Applicant: Shenzhen New Industries Biomedical Engineering Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Product code: Code MRG
Device class: Class 2
Regulation: 21 CFR 862.1825
Advisory panel: Clinical Chemistry
Date received: 2023-08-25
Decision date: 2024-04-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

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