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

    TITAN GEL IFE FREE KAPPA/LAMBA LIGHT CHAIN ANTISER

    K Number: K891683 · Decision Apr 12, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    6
    Applicant Total
    280
    Review Days
    21

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    Basic Information

    Device Name
    TITAN GEL IFE FREE KAPPA/LAMBA LIGHT CHAIN ANTISER
    K Number
    K891683
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5510
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Helena Laboratories
    Date Received
    March 22, 1989
    Decision Date
    April 12, 1989
    Product Code
    CZN
    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
    CZN Iga, Fitc, Antigen, Antiserum, Control

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