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

    AT HOME COCAINE & THC SCREENING TEST, MODEL 9170

    K Number: K991641 · Decision Jun 1, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    17
    Applicant Total
    47
    Review Days
    20

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    Basic Information

    Device Name
    AT HOME COCAINE & THC SCREENING TEST, MODEL 9170
    K Number
    K991641
    Device Class
    FDA unclassified
    Clearance Type
    Special
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Phamatech
    Date Received
    May 12, 1999
    Decision Date
    June 1, 1999
    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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    Other Clearances by Phamatech

    K Number Device Name
    K041578 QUICKSCREEN, MODELS 9177X AND 9178X
    K030447 AT HOME DRUG CUP, MODEL 9150X
    K010833 AT WORK DRUG TEST, MODEL 9177T AWT
    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
    Search all 47 clearances from Phamatech →