BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    LACTOCARD

    K Number: K931901 · Decision Jul 6, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    7
    Applicant Total
    3
    Review Days
    78

    Basic Information

    Device Name
    LACTOCARD
    K Number
    K931901
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.5570
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    TOUCH SCIENTIFIC, INC.
    Date Received
    April 19, 1993
    Decision Date
    July 6, 1993
    Product Code
    DEG
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DEG Lactoferrin, Antigen, Antiserum, Control

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