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

    AESKULSKA BETA2-GLYCO-A

    K Number: K062217 · Decision Dec 13, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    45
    Applicant Total
    6
    Review Days
    134

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    Basic Information

    Device Name
    AESKULSKA BETA2-GLYCO-A
    K Number
    K062217
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5660
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Aesku, Inc.
    Date Received
    August 1, 2006
    Decision Date
    December 13, 2006
    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 Aesku, Inc.

    K Number Device Name
    K051492 AESKULISA ASCA A
    K042644 AESKULISA TTG A AND AESKULISA TTG G
    K040953 AESKULISA ANA HEP-2
    K040463 AESKULISA CARDIOLIPIN AGM
    K032469 AESKULISA ANA 8PRO