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

    N-ASSAY TIA APO B TEST KIT

    K Number: K964296 · Decision Aug 1, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    16
    Applicant Total
    29
    Review Days
    276

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    Basic Information

    Device Name
    N-ASSAY TIA APO B TEST KIT
    K Number
    K964296
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5580
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Crestat Diagnostics, Inc.
    Date Received
    October 29, 1996
    Decision Date
    August 1, 1997
    Product Code
    DER
    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
    DER Alpha-1-Lipoprotein, Antigen, Antiserum, Control

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