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

    DIRECT FLUORESCENT ANTIBODY REAGENT FOR GIARDIA

    K Number: K900604 · Decision Jul 26, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    17
    Applicant Total
    1
    Review Days
    168

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    Basic Information

    Device Name
    DIRECT FLUORESCENT ANTIBODY REAGENT FOR GIARDIA
    K Number
    K900604
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3220
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Biovir Laboratories, Inc.
    Date Received
    February 8, 1990
    Decision Date
    July 26, 1990
    Product Code
    KHW
    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
    KHW Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.

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