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

    AUTOPAK 12 DIGOXIN TEST DELIVERY SYSTEM

    K Number: K791325 · Decision Aug 16, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    13
    Applicant Total
    42
    Review Days
    35

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    Basic Information

    Device Name
    AUTOPAK 12 DIGOXIN TEST DELIVERY SYSTEM
    K Number
    K791325
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3320
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Micromedic Systems
    Date Received
    July 12, 1979
    Decision Date
    August 16, 1979
    Product Code
    DPO
    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
    DPO Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Coated Tube Sep.

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