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

    INNOTRON INNOFLUOR PHEYTOIN REAGENT SET

    K Number: K872563 · Decision Aug 21, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    14
    Applicant Total
    28
    Review Days
    58

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    Basic Information

    Device Name
    INNOTRON INNOFLUOR PHEYTOIN REAGENT SET
    K Number
    K872563
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3350
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Innotron of Oregon, Inc.
    Date Received
    June 24, 1987
    Decision Date
    August 21, 1987
    Product Code
    LGR
    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
    LGR Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total)

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