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

    ECHO TYPE 11 CF ANTIGEN

    K Number: K853157 · Decision Nov 7, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    2
    Applicant Total
    33
    Review Days
    100

    Basic Information

    Device Name
    ECHO TYPE 11 CF ANTIGEN
    K Number
    K853157
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3205
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    HILLCREST BIOLOGICALS
    Date Received
    July 30, 1985
    Decision Date
    November 7, 1985
    Product Code
    GNK
    Advisory Committee
    Microbiology
    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
    GNK Antisera, Cf, Echovirus 1-34

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