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

    SCRIPPSERA THEUMATOID FACTOR REFER. CNTL

    K Number: K810221 · Decision Feb 9, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    143
    Applicant Total
    9
    Review Days
    13

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    Basic Information

    Device Name
    SCRIPPSERA THEUMATOID FACTOR REFER. CNTL
    K Number
    K810221
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5775
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Scripps-Miles, Inc.
    Date Received
    January 27, 1981
    Decision Date
    February 9, 1981
    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 Scripps-Miles, Inc.

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    K811714 HEP-2-CRITHIDIA LUCILIAE ANA TEST KIT
    K811433 SCRIPPSERA COMPLEMENT CONTROL SERA
    K810502 SCRIPPSYSTEM C4 RID KIT
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    K810141 SCRIPPSYSTEM RHEUMATOID FACTOR LATEX KIT
    K810081 SCRIPPSERA ANA REFERENCE CONTROL SERA