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

    PARA 1 SENDAI HEMAGGLUTININ

    K Number: K812365 · Decision Sep 9, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    75
    Review Days
    20

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    Basic Information

    Device Name
    PARA 1 SENDAI HEMAGGLUTININ
    K Number
    K812365
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3400
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Dutchland Laboratories, Inc.
    Date Received
    August 20, 1981
    Decision Date
    September 9, 1981
    Product Code
    GQR
    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
    GQR Antigens, Ha (Including Ha Control), Parainfluenza Virus 1-4

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