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

    ANTI-DSDNA ANTIBODY TEST

    K Number: K921658 · Decision Mar 22, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    7
    Applicant Total
    55
    Review Days
    349

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    Basic Information

    Device Name
    ANTI-DSDNA ANTIBODY TEST
    K Number
    K921658
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5100
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Immco Diagnostics, Inc.
    Date Received
    April 7, 1992
    Decision Date
    March 22, 1993
    Product Code
    LSW
    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
    LSW Anti-Dna Antibody, Antigen And Control

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