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

    GEN-PROBE RAPID DIAGNOSTIC SYSTEM FOR MYCOBACTERIA

    K Number: K864597 · Decision Apr 20, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    14
    Applicant Total
    62
    Review Days
    147

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    Basic Information

    Device Name
    GEN-PROBE RAPID DIAGNOSTIC SYSTEM FOR MYCOBACTERIA
    K Number
    K864597
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3370
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Gen-Probe, Inc.
    Date Received
    November 24, 1986
    Decision Date
    April 20, 1987
    Product Code
    LQF
    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
    LQF Dna-Reagents, Mycobacterium Spp.

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