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

    N-ASSAY TIA ALPHA-1-ANTITRYPSIN TEST KIT

    K Number: K965100 · Decision Jul 14, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    29
    Applicant Total
    29
    Review Days
    206

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    Basic Information

    Device Name
    N-ASSAY TIA ALPHA-1-ANTITRYPSIN TEST KIT
    K Number
    K965100
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5130
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Crestat Diagnostics, Inc.
    Date Received
    December 20, 1996
    Decision Date
    July 14, 1997
    Product Code
    DEM
    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
    DEM Alpha-1-Antitrypsin, Antigen, Antiserum, Control

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    K964294 N-ASSAY TIA APO A1/B MULTI CALIBRATOR
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