BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    FIAGEN DIGOXIN TIME-RESOLVED FLUOROIMMUNOASSAY KIT

    K Number: K884707 · Decision Jan 17, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    14
    Applicant Total
    17
    Review Days
    69

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    Basic Information

    Device Name
    FIAGEN DIGOXIN TIME-RESOLVED FLUOROIMMUNOASSAY KIT
    K Number
    K884707
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3320
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Cyberfluor, Inc.
    Date Received
    November 9, 1988
    Decision Date
    January 17, 1989
    Product Code
    LCS
    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
    LCS Radioimmunoassay, Digoxin (125-I)

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