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

    ELISA FOR HERPES SIMPLEX VIRUS

    K Number: K843077 · Decision Jun 21, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    37
    Applicant Total
    5
    Review Days
    319

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    Basic Information

    Device Name
    ELISA FOR HERPES SIMPLEX VIRUS
    K Number
    K843077
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3305
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Scientific Research
    Date Received
    August 6, 1984
    Decision Date
    June 21, 1985
    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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    Other Clearances by Scientific Research

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