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

    SCRIPPSYSTEM C3 RID KIT

    K Number: K810501 · Decision Apr 8, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    43
    Applicant Total
    9
    Review Days
    43

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    Basic Information

    Device Name
    SCRIPPSYSTEM C3 RID KIT
    K Number
    K810501
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5240
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Scripps-Miles, Inc.
    Date Received
    February 24, 1981
    Decision Date
    April 8, 1981
    Product Code
    CZW
    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
    CZW Complement C3, Antigen, Antiserum, Control

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    Other Clearances by Scripps-Miles, Inc.

    K Number Device Name
    K812453 SCRIPPSYSTEM IMMUNOGLOBIN RID KIT
    K812328 SCRIPPSYSTEM NEPHELOMETRIC ANTISERA KIT
    K811714 HEP-2-CRITHIDIA LUCILIAE ANA TEST KIT
    K811433 SCRIPPSERA COMPLEMENT CONTROL SERA
    K810502 SCRIPPSYSTEM C4 RID KIT
    K810221 SCRIPPSERA THEUMATOID FACTOR REFER. CNTL
    K810141 SCRIPPSYSTEM RHEUMATOID FACTOR LATEX KIT
    K810081 SCRIPPSERA ANA REFERENCE CONTROL SERA