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

    SCRIPPSYSTEM C4 RID KIT

    K Number: K810502 · Decision Apr 8, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    33
    Applicant Total
    9
    Review Days
    43

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    SCRIPPSYSTEM C4 RID KIT
    K Number
    K810502
    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
    DBI
    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
    DBI Complement C4, Antigen, Antiserum, Control

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (DBI), ordered by most recent decision date.

    SPAPLUS ANALYZER

    FDA 510(k)
    FDA Class 2 ·Immunology

    TINA-QUANT COMPLEMENT C4 TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Immunology

    WAKO AUTOKIT C4

    FDA 510(k)
    FDA Class 2 ·Immunology

    RANDOX COMPLEMENT C4

    FDA 510(k)
    FDA Class 2 ·Immunology

    DIMENSION C4 FLEX REAGENT CARTRIDGE

    FDA 510(k)
    FDA Class 2 ·Immunology

    C4 MININEPH ANTISERUM

    FDA 510(k)
    FDA Class 2 ·Immunology
    View all

    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
    K810501 SCRIPPSYSTEM C3 RID KIT
    K810221 SCRIPPSERA THEUMATOID FACTOR REFER. CNTL
    K810141 SCRIPPSYSTEM RHEUMATOID FACTOR LATEX KIT
    K810081 SCRIPPSERA ANA REFERENCE CONTROL SERA