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510(k) Data Aggregation

    K Number
    K980538
    Device Name
    LASER LANCET LB100
    Manufacturer
    TRANSMEDICA INTL., INC.
    Date Cleared
    1998-07-09

    (148 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRANSMEDICA INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Laser Lancet® is intended for use for the perforation of skin to draw capillary blood for screening purposes.
    Device Description
    The Laser Lancet® LB100 is a portable Er:YAG laser. The beam is focused within the unit and exits through a tube placed in the aperture allowing the focused beam to strike the finger of a patient placed against the unit's tip and perforate the skin. The resulting blood sample is used for clinical chemistry screening purposes.
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