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

    ZETAPHASE-DIG

    K Number: K822053 · Decision Jul 27, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    16
    Applicant Total
    1
    Review Days
    14

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    Basic Information

    Device Name
    ZETAPHASE-DIG
    K Number
    K822053
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3320
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Biological & Diagnostic Products
    Date Received
    July 13, 1982
    Decision Date
    July 27, 1982
    Product Code
    DON
    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
    DON Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Solid Phase Sep.

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