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

    IL TEST PHENYTOIN

    K Number: K860286 · Decision Mar 5, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    43
    Applicant Total
    7
    Review Days
    36

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    Basic Information

    Device Name
    IL TEST PHENYTOIN
    K Number
    K860286
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3350
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Allied Instrumentation Laboratory
    Date Received
    January 28, 1986
    Decision Date
    March 5, 1986
    Product Code
    DIP
    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
    DIP Enzyme Immunoassay, Diphenylhydantoin

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    Other Clearances by Allied Instrumentation Laboratory

    K Number Device Name
    K861901 MULTI-4 CO-OXIMETER CONTROL
    K860365 PHENOBARBITAL TEST SYSTEM
    K853858 IL TEST THEOPHYLLINE ASSAY
    K852676 IL SYSTEM 1304 & 1306, PH/BLOOD GAS ANALYZERS
    K851933 CLINICAL CHEMISTRY ANALYTICAL SYSTEM
    K850748 I-L TEST, DIRECT BILIRUBIN SET