BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    EMIT CAFFEINE CONTROL

    K Number: K861511 · Decision Jun 13, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    82
    Applicant Total
    2
    Review Days
    51

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    Basic Information

    Device Name
    EMIT CAFFEINE CONTROL
    K Number
    K861511
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.3280
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Syva / A Syntex Co.
    Date Received
    April 23, 1986
    Decision Date
    June 13, 1986
    Product Code
    LAS
    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
    LAS Drug Specific Control Materials

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