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

    THE DPC COAT-A-COUNT SERUM MORPHINE RIA KIT

    K Number: K863913 · Decision Mar 19, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    11
    Applicant Total
    321
    Review Days
    162

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    Basic Information

    Device Name
    THE DPC COAT-A-COUNT SERUM MORPHINE RIA KIT
    K Number
    K863913
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3640
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Diagnostic Products Corp.
    Date Received
    October 8, 1986
    Decision Date
    March 19, 1987
    Product Code
    DOE
    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
    DOE Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep.

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