BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    EZ COMPLEMENT REAGENTS, 78N2212

    K Number: K870351 · Decision Mar 13, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    3
    Applicant Total
    68
    Review Days
    43

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    Basic Information

    Device Name
    EZ COMPLEMENT REAGENTS, 78N2212
    K Number
    K870351
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.4100
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Diamedix Corp.
    Date Received
    January 29, 1987
    Decision Date
    March 13, 1987
    Product Code
    DHL
    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
    DHL Protein, Complement, Antigen, Antiserum, Control

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