BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)

    K Number: K192727 · Decision May 20, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    143
    Applicant Total
    2
    Review Days
    236

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    Basic Information

    Device Name
    K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)
    K Number
    K192727
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5775
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Kamiya Biomedical Company
    Date Received
    September 27, 2019
    Decision Date
    May 20, 2020
    Product Code
    DHR
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DHR System, Test, Rheumatoid Factor

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    Other Clearances by Kamiya Biomedical Company

    K Number Device Name
    K121232 K-ASSAY (R) FERRITIN REAGENT, K-ASSAY (R) FERRITIN CALIBRATOR