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

    QUICK SCREEN ONE STEP AMPHETAMINE TEST

    K Number: K972577 · Decision Aug 20, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    3
    Applicant Total
    47
    Review Days
    41

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    Basic Information

    Device Name
    QUICK SCREEN ONE STEP AMPHETAMINE TEST
    K Number
    K972577
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3100
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Phamatech
    Date Received
    July 10, 1997
    Decision Date
    August 20, 1997
    Product Code
    DIT
    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
    DIT Thin Layer Chromatography, Amphetamine

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    Other Clearances by Phamatech

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    K010836 AT WORK DRUG TEST, MODEL 9147T AWT
    K010654 AT HOME DRUG TEST, MODEL 9078 T
    K010653 AT HOME DRUG TEST, MODEL 9068 T
    K010655 AT HOME DRUG TESTT, MODEL 9150 T
    K010645 AT HOME DRUG TEST, MODEL 9063 T
    K010646 AT HOME DRUG TEST, MODEL 9083 T
    K010651 AT HOME DRUG TEST, MODEL 9133 T
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