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

    RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.M

    K Number: K772079 · Decision Feb 3, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    2
    Applicant Total
    11
    Review Days
    92

    Basic Information

    Device Name
    RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.M
    K Number
    K772079
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5550
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    GELMAN INSTRUMENT CO.
    Date Received
    November 3, 1977
    Decision Date
    February 3, 1978
    Product Code
    DFL
    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
    DFL Igm, Ferritin, Antigen, Antiserum, Control

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    Other Clearances by GELMAN INSTRUMENT CO.

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    K772080 RADIAL IMMUNODIFFUSION KIT-ALPH-L-ANTIT
    K772325 DENSITOMETER 18, COMPUTING, AUTO.
    K771812 LIPPOPROTEIN ELECTROPHORESIS REAGENT SET
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