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

    DIGOXIN FPIA CALIBRATORS

    K Number: K872328 · Decision Jul 7, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Same Product Code
    122
    Applicant Total
    231
    Review Days
    20

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    Basic Information

    Device Name
    DIGOXIN FPIA CALIBRATORS
    K Number
    K872328
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3200
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Sigma Chemical Co.
    Date Received
    June 17, 1987
    Decision Date
    July 7, 1987
    Product Code
    DLJ
    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
    DLJ Calibrators, Drug Specific

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