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

    DRUGALYZER DTK-1000 KIT PRESUMPTIVE DRUG

    K Number: K792282 · Decision Feb 29, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    11
    Applicant Total
    1
    Review Days
    108

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    Basic Information

    Device Name
    DRUGALYZER DTK-1000 KIT PRESUMPTIVE DRUG
    K Number
    K792282
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3870
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    California Medical Developments, Inc.
    Date Received
    November 13, 1979
    Decision Date
    February 29, 1980
    Product Code
    DKE
    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
    DKE Reagents, Test, Tetrahydrocannabinol

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