BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    GC-TECT

    K Number: K840159 · Decision Jan 30, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    82
    Applicant Total
    3
    Review Days
    17

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    Basic Information

    Device Name
    GC-TECT
    K Number
    K840159
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.2410
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Uti-Tect, Inc.
    Date Received
    January 13, 1984
    Decision Date
    January 30, 1984
    Product Code
    JTY
    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
    JTY Culture Media, For Isolation Of Pathogenic Neisseria

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    Other Clearances by Uti-Tect, Inc.

    K Number Device Name
    K840160 B-STREP-TECT-II
    K812581 SENSI-TECT