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

    CAPILLARY'S IMMUNOTYPING (PN 2100)

    K Number: K042939 · Decision Jun 27, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    62
    Applicant Total
    2
    Review Days
    245

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    Basic Information

    Device Name
    CAPILLARY'S IMMUNOTYPING (PN 2100)
    K Number
    K042939
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5550
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Sebia, Inc.
    Date Received
    October 25, 2004
    Decision Date
    June 27, 2005
    Product Code
    DFH
    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
    DFH Kappa, Antigen, Antiserum, Control

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    Other Clearances by Sebia, Inc.

    K Number Device Name
    K070486 CAPILLARYS URINE (PN 2012)