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

    ANTISERA TO HUMAN FERRITIN

    K Number: K822472 · Decision Sep 30, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    41
    Registration Numbers
    41
    Same Product Code
    86
    Applicant Total
    40
    Review Days
    44

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    Basic Information

    Device Name
    ANTISERA TO HUMAN FERRITIN
    K Number
    K822472
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5340
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Kent Laboratories, Inc.
    Date Received
    August 17, 1982
    Decision Date
    September 30, 1982
    Product Code
    DBF
    Advisory Committee
    Immunology
    Review Advisory Committee
    MI
    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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    K951968 HUMAN C1Q RADIAL IMMUNODIFFUSION KIT
    K950102 HUMAN C-5 RADIAL IMMUNODIFFUSION KIT
    K850683 72 DETERM. SIZE RADIAL IMMUNODIFFUSION TEST ALPHA2
    K850682 72 DETERM. SIZE RADIAL IMMUNO. TEST HUMAN CERULOPL
    K850691 ANTISERUM TO HUMAN APOLIPOPROTEIN A-I
    K850690 ANTISERUM TO HUMAN APOLIPOPROTEIN B
    K850686 ANTISERUM TO HUMAN PREALBUMIN
    K831961 IMMUNODIFFUSION TEST HUMAN ANTITHROMBIN
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