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

    LIFESIGN MET, STATUS STIK MET, ACCUSIGN STIK MET, ACCUSTIK MET, ACCUSIGN MET, STATUS DS MET

    K Number: K014192 · Decision May 23, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    17
    Applicant Total
    72
    Review Days
    153

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    Basic Information

    Device Name
    LIFESIGN MET, STATUS STIK MET, ACCUSIGN STIK MET, ACCUSTIK MET, ACCUSIGN MET, STATUS DS MET
    K Number
    K014192
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Princeton BioMeditech Corp.
    Date Received
    December 21, 2001
    Decision Date
    May 23, 2002
    Product Code
    MVO
    Advisory Committee
    Unknown
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MVO Kit, Test, Multiple, Drugs Of Abuse, Over The Counter

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