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

    DSDNA IMMUNOGLOBULIN EIA TEST SYSTEM

    K Number: K960182 · Decision Mar 20, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    28
    Applicant Total
    8
    Review Days
    64

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    Basic Information

    Device Name
    DSDNA IMMUNOGLOBULIN EIA TEST SYSTEM
    K Number
    K960182
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5100
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mardx Diagnostics, Inc.
    Date Received
    January 16, 1996
    Decision Date
    March 20, 1996
    Product Code
    LRM
    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
    LRM Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control

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    Other Clearances by Mardx Diagnostics, Inc.

    K Number Device Name
    K964787 MARDX ENA IGG IMMUNOSTRIPE TEST SYSTEM / MARDX ENA IGG MARSTRIPE TEST SYSTEM
    K951709 MARDX LYME DISEASE (IGM) MARBLOT STRIP TEST SYSTEM
    K950829 MARDX LYME DISEASE (IGG) MARBLOT STRIP TEST SYSTEM
    K894293 MARDX LYME DISEASE EIA (IGM) TEST SYSTEM
    K894224 MARDX LYME DISEASE EIA (IGG) TEST SYSTEM
    K892206 MARDX LLYME DISEASE EIA (IGG & IGM) TEST SYSTEM
    K890053 MARDX LYME DISEASE IGG IFA TEST SYSTEM