BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    DETECTABUSE DRUG CONTROLS

    K Number: K890406 · Decision Feb 10, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    41
    Registration Numbers
    41
    Same Product Code
    201
    Applicant Total
    2
    Review Days
    17

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    Basic Information

    Device Name
    DETECTABUSE DRUG CONTROLS
    K Number
    K890406
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.3280
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Eastern Laboratories, Ltd.
    Date Received
    January 24, 1989
    Decision Date
    February 10, 1989
    Product Code
    DIF
    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
    DIF Drug Mixture Control Materials

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    Other Clearances by Eastern Laboratories, Ltd.

    K Number Device Name
    K880512 DRUG MIXTURE CONTROL IN URINE