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

    METHADONE EIA ASSAY

    K Number: K972526 · Decision Aug 4, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    62
    Applicant Total
    66
    Review Days
    39

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    Basic Information

    Device Name
    METHADONE EIA ASSAY
    K Number
    K972526
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3620
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Diagnostic Reagents, Inc.
    Date Received
    June 26, 1997
    Decision Date
    August 4, 1997
    Product Code
    DJR
    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
    DJR Enzyme Immunoassay, Methadone

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    Other Clearances by Diagnostic Reagents, Inc.

    K Number Device Name
    K983268 MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAY
    K983812 NAPA EIA ASSAY
    K983323 DIGOXIN IMMUNOASSAY
    K983280 VANCOMYCIN EIA ASSAY
    K983159 DRUGS OF ABUSE URINE CALIBRATORS AND CONTROLS
    K973102 LIDOCAINE EIA ASSAY
    K972835 50NG/ML COCAINE METABOLITE CALIBRATOR
    K964212 QUINIDINE ENZYME IMMUNOASSAY
    K963835 DIGOXIN ENZYME IMMUNOASSAY
    K962463 PROCAINAMIDE ENZYME IMMUNOASSAY
    Search all 66 clearances from Diagnostic Reagents, Inc. →