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

    MICRO-STRIP FOR OPIATE METABOLITES

    K Number: K973761 · Decision Dec 24, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    100
    Registration Numbers
    100
    Same Product Code
    214
    Applicant Total
    10
    Review Days
    83

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    Basic Information

    Device Name
    MICRO-STRIP FOR OPIATE METABOLITES
    K Number
    K973761
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3650
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Microdiagnostics, Inc.
    Date Received
    October 2, 1997
    Decision Date
    December 24, 1997
    Product Code
    DJG
    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
    DJG Enzyme Immunoassay, Opiates

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    Other Clearances by Microdiagnostics, Inc.

    K Number Device Name
    K011952 DRUGS OF ABUSE MULTI-TEST STRIP
    K991516 MICRO-STRIP FOR MARIJUANA METABOLITES
    K991505 MICRO-STRIP FOR PHENCYCLIDINE METABOLITES
    K981388 MICRO-STRIP FOR COCAINE METABOLITES
    K974611 MICRO-STRIP FOR AMPHETAMINE METABOLITES
    K932304 MICRO EIA FOR AMPHETAMINE METABOLITES
    K923468 MICRO EIA FOR OPIATE METABOLITES
    K914533 MICRO EIA FOR COCAINE METABOLITES
    K914490 MICRO EIA FOR MARIJUANA METABOLITES