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

    HCC-MYCOBACTERIA STAIN KIT

    K Number: K833131 · Decision Oct 27, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    42
    Applicant Total
    1
    Review Days
    44

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    Basic Information

    Device Name
    HCC-MYCOBACTERIA STAIN KIT
    K Number
    K833131
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2660
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Dr. C.V. Jacob
    Date Received
    September 13, 1983
    Decision Date
    October 27, 1983
    Product Code
    LIB
    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
    LIB Device, General Purpose, Microbiology, Diagnostic

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