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

    DIRECT IMMUNOFLUOR. ANTIBODY TEST KIT

    K Number: K810856 · Decision May 5, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    35
    Review Days
    36

    Basic Information

    Device Name
    DIRECT IMMUNOFLUOR. ANTIBODY TEST KIT
    K Number
    K810856
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3120
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    BARTELS IMMUNODIAGNOSTIC SUPPLIES, INC.
    Date Received
    March 30, 1981
    Decision Date
    May 5, 1981
    Product Code
    GPT
    Advisory Committee
    Microbiology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GPT Antiserum, Cf, Psittacosis (Chlamydia Group)

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