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

    SEROCARD HSV IGG ANTIBODY TEST KIT

    K Number: K903070 · Decision Aug 9, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    37
    Applicant Total
    20
    Review Days
    28

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    Basic Information

    Device Name
    SEROCARD HSV IGG ANTIBODY TEST KIT
    K Number
    K903070
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3305
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Disease Detection International, Inc.
    Date Received
    July 12, 1990
    Decision Date
    August 9, 1990
    Product Code
    LGC
    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
    LGC Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific

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