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

    CHROMALEX RHEUMATOID FACTOR LATEX TEST SYSTEM

    K Number: K953261 · Decision Aug 15, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    143
    Applicant Total
    5
    Review Days
    34

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    Basic Information

    Device Name
    CHROMALEX RHEUMATOID FACTOR LATEX TEST SYSTEM
    K Number
    K953261
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5775
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Shared Systems, Inc.
    Date Received
    July 12, 1995
    Decision Date
    August 15, 1995
    Product Code
    DHR
    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
    DHR System, Test, Rheumatoid Factor

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    Other Clearances by Shared Systems, Inc.

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    K950073 MYCOPLASMA PNEUMONIAE ANTIBODY LATEX AGGLUTINATION TEST SYSTEM
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