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

    DART DIGOXIN ASSAY

    K Number: K864802 · Decision Feb 12, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    14
    Applicant Total
    101
    Review Days
    65

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    Basic Information

    Device Name
    DART DIGOXIN ASSAY
    K Number
    K864802
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3320
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Coulter Electronics, Inc.
    Date Received
    December 9, 1986
    Decision Date
    February 12, 1987
    Product Code
    LCS
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LCS Radioimmunoassay, Digoxin (125-I)

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