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

    SCREENERS COCAINE TEST; DRUGSCREEN DIP COCAINE TEST

    K Number: K000350 · Decision Apr 11, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    97
    Registration Numbers
    97
    Same Product Code
    144
    Applicant Total
    8
    Review Days
    68

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    Basic Information

    Device Name
    SCREENERS COCAINE TEST; DRUGSCREEN DIP COCAINE TEST
    K Number
    K000350
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3250
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Drug Detection Devices, Ltd.
    Date Received
    February 3, 2000
    Decision Date
    April 11, 2000
    Product Code
    DIO
    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
    DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites

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    Other Clearances by Drug Detection Devices, Ltd.

    K Number Device Name
    K000452 SCREENERS METHAMPHETAMINE TEST, DRUGSCREEN DIP METHAMPHETAMINE TEST
    K000522 SCREENERS BARBITURATE TEST, DRUGSCREEN DIP BARBITURATE TEST
    K000402 SCREENERS PHENCYCLIDINE (PCP) TEST, DRUGSCREEN DIP PHENCYCLIDINE (PCP) TEST
    K000400 SCREENERS AMPHETAMINE TEST, DRUGSCREEN DIP AMPHETAMINE TEST
    K000273 SCREENERS OPIATES TEST DRUGSCREEN DIP OPIATES TEST
    K000449 SCREENERS BENZODIAZEPINE (BZD) TEST, DRUG SCREEN DIP BENZODIAZEPINE (BZD) TEST
    K992949 SCREENERS MARIJUANA TEST, DRUGSCREEN DIP MARIJUANA TEST