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

    ACCUSIGN MTD-RAPID ONE-STEP METHADONE ASSAY

    K Number: K962673 · Decision Aug 15, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    62
    Applicant Total
    72
    Review Days
    37

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    Basic Information

    Device Name
    ACCUSIGN MTD-RAPID ONE-STEP METHADONE ASSAY
    K Number
    K962673
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3620
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Princeton BioMeditech Corp.
    Date Received
    July 9, 1996
    Decision Date
    August 15, 1996
    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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