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

    MICROBIO. PROD. FLUORESCENT ANTIBODY

    K Number: K770801 · Decision May 25, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    1
    Applicant Total
    6
    Review Days
    23

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    Basic Information

    Device Name
    MICROBIO. PROD. FLUORESCENT ANTIBODY
    K Number
    K770801
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3255
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Pfizer Pharmaceuticals
    Date Received
    May 2, 1977
    Decision Date
    May 25, 1977
    Product Code
    GMY
    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
    GMY Antisera, Fluorescent, All Types, Escherichia Coli

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