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

    N-ASSAY TIA IGG

    K Number: K933972 · Decision Mar 22, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    28
    Applicant Total
    29
    Review Days
    221

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    Basic Information

    Device Name
    N-ASSAY TIA IGG
    K Number
    K933972
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5510
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Crestat Diagnostics, Inc.
    Date Received
    August 13, 1993
    Decision Date
    March 22, 1994
    Product Code
    CFF
    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
    CFF Immunoelectrophoretic, Immunoglobulins, (G, A, M)

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