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

    RHIGENE DSG-1 & DSG-3 ELISA TEST SYSTEM, MODEL 7680 E

    K Number: K000336 · Decision Jun 9, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    1
    Applicant Total
    15
    Review Days
    127

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    Basic Information

    Device Name
    RHIGENE DSG-1 & DSG-3 ELISA TEST SYSTEM, MODEL 7680 E
    K Number
    K000336
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5660
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Rhigene, Inc.
    Date Received
    February 3, 2000
    Decision Date
    June 9, 2000
    Product Code
    NBO
    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
    NBO Autoantibodies, Skin (Desmoglein 1 And Desmoglein 3)

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