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

    STRATUS PHENOBARBITAL FLUOROMETRIC ENZ

    K Number: K830701 · Decision May 13, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    7
    Applicant Total
    149
    Review Days
    67

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    Basic Information

    Device Name
    STRATUS PHENOBARBITAL FLUOROMETRIC ENZ
    K Number
    K830701
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3660
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    American Dade
    Date Received
    March 7, 1983
    Decision Date
    May 13, 1983
    Product Code
    LET
    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
    LET Fluorescent Immunoassay, Phenobarbital

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