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

    THERATEST EL-BETA2GPI (IGM-IGG-IGA), THERATEST EL--BETA2GPI SCR

    K Number: K092757 · Decision Oct 9, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    45
    Applicant Total
    1
    Review Days
    30

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    Basic Information

    Device Name
    THERATEST EL-BETA2GPI (IGM-IGG-IGA), THERATEST EL--BETA2GPI SCR
    K Number
    K092757
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    866.5660
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Thera-Test Laboratories, Inc.
    Date Received
    September 9, 2009
    Decision Date
    October 9, 2009
    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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