BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

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

    K Number: K232587 · Decision Apr 12, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    51
    Registration Numbers
    51
    Same Product Code
    45
    Applicant Total
    5
    Review Days
    231

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer
    K Number
    K232587
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1825
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen New Industries Biomedical Engineering Co., Ltd.
    Date Received
    August 25, 2023
    Decision Date
    April 12, 2024
    Product Code
    MRG
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MRG System, Test, Vitamin D

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (MRG), ordered by most recent decision date.

    ALFIS Vitamin D, ALFIS-3 Analyzer

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Access 25(OH) Vitamin D Total

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Elecsys Vitamin D total III

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ADVIA Centaur Vitamin D Total (VitD)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MAGLUMI 2000 25-OH Vitamin D

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    BioPlex 2200 25-OH Vitamin D Kit

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry
    View all

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

    K Number Device Name
    K192547 MAGLUMI 2000 HCG/ß-HCG
    K191499 MAGLUMI 2000 25-OH Vitamin D
    K182423 MAGLUMI 2000 FT4
    K162698 MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer