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

    STANDARDIZE TGCL & TGCH

    K Number: K781376 · Decision Sep 14, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    7
    Applicant Total
    73
    Review Days
    36

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    Basic Information

    Device Name
    STANDARDIZE TGCL & TGCH
    K Number
    K781376
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2900
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    American Monitor Corp.
    Date Received
    August 9, 1978
    Decision Date
    September 14, 1978
    Product Code
    JTX
    Advisory Committee
    Microbiology
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JTX Transport Systems, Anaerobic

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