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

    IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN (FER)REAGENT, IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN CALIBRATOR

    K Number: K983340 · Decision Dec 14, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    41
    Registration Numbers
    41
    Same Product Code
    86
    Applicant Total
    270
    Review Days
    82

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    Basic Information

    Device Name
    IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN (FER)REAGENT, IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN CALIBRATOR
    K Number
    K983340
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5340
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Beckman Coulter, Inc.
    Date Received
    September 23, 1998
    Decision Date
    December 14, 1998
    Product Code
    DBF
    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
    DBF Ferritin, Antigen, Antiserum, Control

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