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

    IMMUNOSCAN DIRECT HEMOPHILUS INFLUENZAE TYPE B TES

    K Number: K854490 · Decision Dec 27, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    5
    Applicant Total
    24
    Review Days
    45

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    Basic Information

    Device Name
    IMMUNOSCAN DIRECT HEMOPHILUS INFLUENZAE TYPE B TES
    K Number
    K854490
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3300
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    American Micro Scan
    Date Received
    November 12, 1985
    Decision Date
    December 27, 1985
    Product Code
    GRP
    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
    GRP Antisera, All Types, H. Influenza

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