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

    POLYMED THERAPEUTICS FASTEP DIPSTICK DRUGS OF ABUSE SCREEN DEVICE AND DIPCARD DRUGS OF ABUSE SCREEN DEVICE

    K Number: K121065 · Decision May 24, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    96
    Registration Numbers
    96
    Same Product Code
    224
    Applicant Total
    5
    Review Days
    413

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    Basic Information

    Device Name
    POLYMED THERAPEUTICS FASTEP DIPSTICK DRUGS OF ABUSE SCREEN DEVICE AND DIPCARD DRUGS OF ABUSE SCREEN DEVICE
    K Number
    K121065
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3100
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Polymed Therapeutics, Inc.
    Date Received
    April 6, 2012
    Decision Date
    May 24, 2013
    Product Code
    DKZ
    Advisory Committee
    Clinical Toxicology
    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
    DKZ Enzyme Immunoassay, Amphetamine

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    Other Clearances by Polymed Therapeutics, Inc.

    K Number Device Name
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    K132834 FASTEP S10 HCG SERUM/URINE COMBO TEST
    K122907 FASTEP AT-HOME PREGNANCY, HCG, OVER THE COUNTER
    K112101 FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS