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

    INNOFLUOR THEOPHYLLINE

    K Number: K850629 · Decision Mar 12, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    12
    Applicant Total
    6
    Review Days
    21

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    Basic Information

    Device Name
    INNOFLUOR THEOPHYLLINE
    K Number
    K850629
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3880
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Innotron Diagnostics
    Date Received
    February 19, 1985
    Decision Date
    March 12, 1985
    Product Code
    LGS
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LGS Fluorescence Polarization Immunoassay, Theophylline

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    Other Clearances by Innotron Diagnostics

    K Number Device Name
    K844721 INNOFLUOR PRIMIDONE
    K841865 INNOFLOUR GENTAMICIN
    K841866 INNOFLOUR TOBRAMYCIN
    K841707 INNOFLUOR PHENOBARBITAL
    K841706 INNOFLUOR PHENYTOIN