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

    LIQUISOL DIGOXIN RIA TEST KIT

    K Number: K780207 · Decision Feb 23, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    16
    Applicant Total
    11
    Review Days
    16

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    Basic Information

    Device Name
    LIQUISOL DIGOXIN RIA TEST KIT
    K Number
    K780207
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3320
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Damon Corp.
    Date Received
    February 7, 1978
    Decision Date
    February 23, 1978
    Product Code
    DON
    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
    DON Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Solid Phase Sep.

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