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

    TILL-U=TEST

    K Number: K780109 · Decision Jan 31, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    43
    Applicant Total
    2
    Review Days
    12

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    Basic Information

    Device Name
    TILL-U=TEST
    K Number
    K780109
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2660
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Clinifax Industries, Ltd.
    Date Received
    January 19, 1978
    Decision Date
    January 31, 1978
    Product Code
    JXA
    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
    JXA Kit, Screening, Urine

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    Other Clearances by Clinifax Industries, Ltd.

    K Number Device Name
    K781421 BIOSCAN E12