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

    INNOFLUOR(TM) DIGITOXIN REAGENT SET

    K Number: K913187 · Decision Sep 23, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    19
    Applicant Total
    6
    Review Days
    67

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    Basic Information

    Device Name
    INNOFLUOR(TM) DIGITOXIN REAGENT SET
    K Number
    K913187
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3300
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Intl. Bioclinical, Inc.
    Date Received
    July 18, 1991
    Decision Date
    September 23, 1991
    Product Code
    LFM
    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
    LFM Enzyme Immunoassay, Digitoxin

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