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

    MARDX LYME DISEASE (IGG) MARBLOT STRIP TEST SYSTEM

    K Number: K950829 · Decision Jun 5, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30
    Same Product Code
    110
    Applicant Total
    8
    Review Days
    468

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    Basic Information

    Device Name
    MARDX LYME DISEASE (IGG) MARBLOT STRIP TEST SYSTEM
    K Number
    K950829
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3830
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mardx Diagnostics, Inc.
    Date Received
    February 23, 1995
    Decision Date
    June 5, 1996
    Product Code
    LSR
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LSR Reagent, Borrelia Serological Reagent

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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
    K960182 DSDNA IMMUNOGLOBULIN EIA 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