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

    DUOTIP-TEST

    K Number: K941820 · Decision Sep 2, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    24
    Applicant Total
    2
    Review Days
    142

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    Basic Information

    Device Name
    DUOTIP-TEST
    K Number
    K941820
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5570
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Lincoln Diagnostics, Inc.
    Date Received
    April 13, 1994
    Decision Date
    September 2, 1994
    Product Code
    SCL
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    SCL Allergen And Vaccine Delivery Needles

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    Other Clearances by Lincoln Diagnostics, Inc.

    K Number Device Name
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