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

    ANTI-DNASE B REAGENT SYSTEM

    K Number: K790997 · Decision Jul 24, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    0
    Applicant Total
    41
    Review Days
    56

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    Basic Information

    Device Name
    ANTI-DNASE B REAGENT SYSTEM
    K Number
    K790997
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3720
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Calbiochem-Behring Corp.
    Date Received
    May 29, 1979
    Decision Date
    July 24, 1979
    Product Code
    GTR
    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
    GTR Antideoxyribonuclease, Streptococcus Spp.

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