BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGM, MODEL FBGP 100M

    K Number: K031177 · Decision Jun 19, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    45
    Applicant Total
    24
    Review Days
    66

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    Basic Information

    Device Name
    DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGM, MODEL FBGP 100M
    K Number
    K031177
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5660
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Axis-Shield Diagnostics, Ltd.
    Date Received
    April 14, 2003
    Decision Date
    June 19, 2003
    Product Code
    MSV
    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
    MSV System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)

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