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

    INNOFLUOR PHENOBARBITAL

    K Number: K841707 · Decision May 23, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    11
    Applicant Total
    6
    Review Days
    30

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    Basic Information

    Device Name
    INNOFLUOR PHENOBARBITAL
    K Number
    K841707
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3660
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Innotron Diagnostics
    Date Received
    April 23, 1984
    Decision Date
    May 23, 1984
    Product Code
    LGQ
    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
    LGQ Fluorescence Polarization Immunoassay, Phenobarbital

    Similar 510(k) Clearances

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    Other Clearances by Innotron Diagnostics

    K Number Device Name
    K850629 INNOFLUOR THEOPHYLLINE
    K844721 INNOFLUOR PRIMIDONE
    K841865 INNOFLOUR GENTAMICIN
    K841866 INNOFLOUR TOBRAMYCIN
    K841706 INNOFLUOR PHENYTOIN