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

    AMERLITE FERRITIN II ASSAY

    K Number: K952286 · Decision Jun 20, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    41
    Registration Numbers
    41
    Same Product Code
    86
    Applicant Total
    33
    Review Days
    35

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    Basic Information

    Device Name
    AMERLITE FERRITIN II ASSAY
    K Number
    K952286
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5340
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Johnson & Johnson Clinical Diagnostics, Inc.
    Date Received
    May 16, 1995
    Decision Date
    June 20, 1995
    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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