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

    FLUORESCENT ANTIBODY CONJUGATE FOR GP.A

    K Number: K812013 · Decision Jul 28, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    1
    Applicant Total
    2
    Review Days
    11

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    Basic Information

    Device Name
    FLUORESCENT ANTIBODY CONJUGATE FOR GP.A
    K Number
    K812013
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3740
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Springwood Microbiologicals
    Date Received
    July 17, 1981
    Decision Date
    July 28, 1981
    Product Code
    GTX
    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
    GTX Antisera, Fluorescent, All Groups, Streptococcus Spp.

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    K813339 DIRECT FA CONJUGATE FOR LEGIONELLA SP