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

    IMMPULSE DIGOXIN ASSAY REAGENTS

    K Number: K842571 · Decision Aug 16, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    84
    Applicant Total
    2
    Review Days
    44

    Basic Information

    Device Name
    IMMPULSE DIGOXIN ASSAY REAGENTS
    K Number
    K842571
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3320
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    AKTIS CORP.
    Date Received
    July 3, 1984
    Decision Date
    August 16, 1984
    Product Code
    KXT
    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
    KXT Enzyme Immunoassay, Digoxin

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    Other Clearances by AKTIS CORP.

    K Number Device Name
    K842554 IMMPULSE CORTISOL ASSAY REAGENTS