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

    AMTEC RHEUMATOID FACTOR LATEX AGGLUTINATION KIT

    K Number: K873064 · Decision Nov 4, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    143
    Applicant Total
    2
    Review Days
    91

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    Basic Information

    Device Name
    AMTEC RHEUMATOID FACTOR LATEX AGGLUTINATION KIT
    K Number
    K873064
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5775
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Amtec Diagnostics International, Inc.
    Date Received
    August 5, 1987
    Decision Date
    November 4, 1987
    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 Amtec Diagnostics International, Inc.

    K Number Device Name
    K882998 ACUTE PHASE C-REACTIVE PROTEIN LATEX AGGLU. TEST