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

    EMDS ANTIEPILEPTIC DRUG CALIBRATORS ITEM #67630/95

    K Number: K862403 · Decision Jul 11, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    93
    Applicant Total
    14
    Review Days
    15

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    Basic Information

    Device Name
    EMDS ANTIEPILEPTIC DRUG CALIBRATORS ITEM #67630/95
    K Number
    K862403
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3200
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Diagnostic Systems
    Date Received
    June 26, 1986
    Decision Date
    July 11, 1986
    Product Code
    DKB
    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
    DKB Calibrators, Drug Mixture

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