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

    AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGA ELISA

    K Number: K030397 · Decision Mar 21, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    45
    Applicant Total
    4
    Review Days
    43

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    Basic Information

    Device Name
    AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGA ELISA
    K Number
    K030397
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5660
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Hycor Biomedical , Ltd.
    Date Received
    February 6, 2003
    Decision Date
    March 21, 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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    Other Clearances by Hycor Biomedical , Ltd.

    K Number Device Name
    K043433 AUTOSTAT II ANTI-TISSUE TRANSGLUTAMINASE IGG ELISA
    K033744 AUTOSTAT II ANTI-TISUE TRANSGLUTAMINASE IGA ELISA
    K030741 AUTOSTAT II ANTI-CARDIOLIPIN IGA ELISA