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

    HERPES SIMPLEX VIRUS SEROLOGICAL REAGENT

    K Number: K803132 · Decision Jan 28, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    36
    Applicant Total
    14
    Review Days
    47

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    Basic Information

    Device Name
    HERPES SIMPLEX VIRUS SEROLOGICAL REAGENT
    K Number
    K803132
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3305
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Microbiological Research Corp.
    Date Received
    December 12, 1980
    Decision Date
    January 28, 1981
    Product Code
    GQL
    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
    GQL Antisera, Fluorescent, Herpesvirus Hominis 1,2

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