BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    SCRIPPSERA COMPLEMENT CONTROL SERA

    K Number: K811433 · Decision Jun 16, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    3
    Applicant Total
    9
    Review Days
    25

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    Basic Information

    Device Name
    SCRIPPSERA COMPLEMENT CONTROL SERA
    K Number
    K811433
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.4100
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Scripps-Miles, Inc.
    Date Received
    May 22, 1981
    Decision Date
    June 16, 1981
    Product Code
    DHL
    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
    DHL Protein, Complement, Antigen, Antiserum, Control

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    Other Clearances by Scripps-Miles, Inc.

    K Number Device Name
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    K812328 SCRIPPSYSTEM NEPHELOMETRIC ANTISERA KIT
    K811714 HEP-2-CRITHIDIA LUCILIAE ANA TEST KIT
    K810502 SCRIPPSYSTEM C4 RID KIT
    K810501 SCRIPPSYSTEM C3 RID KIT
    K810221 SCRIPPSERA THEUMATOID FACTOR REFER. CNTL
    K810141 SCRIPPSYSTEM RHEUMATOID FACTOR LATEX KIT
    K810081 SCRIPPSERA ANA REFERENCE CONTROL SERA