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

    CORNING PARAPROTEIN SCREENING

    K Number: K790667 · Decision Jul 24, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    28
    Applicant Total
    111
    Review Days
    109

    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
    CORNING PARAPROTEIN SCREENING
    K Number
    K790667
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5510
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Corning Medical & Scientific
    Date Received
    April 6, 1979
    Decision Date
    July 24, 1979
    Product Code
    CFF
    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
    CFF Immunoelectrophoretic, Immunoglobulins, (G, A, M)

    Similar 510(k) Clearances

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

    HYDRASHIFT 2/4 isatuximab

    FDA 510(k)
    FDA Class 2 ·Immunology

    CAPI 3 Immunotyping, Capillarys 3 Tera

    FDA 510(k)
    FDA Class 2 ·Immunology

    HYDRASHIFT 2/4 daratumumab

    FDA 510(k)
    FDA Class 2 ·Immunology

    HYDRASHIFT 2/4 daratumumab, daratumumab Control

    FDA 510(k)
    FDA Class 2 ·Immunology

    CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL

    FDA 510(k)
    FDA Class 2 ·Immunology

    MINICAP Immunotyping using the MINICAP and the MINICAP FLEX-PIERCING

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

    Other Clearances by Corning Medical & Scientific

    K Number Device Name
    K875122 DISPOSABLE STERILE SYRINGE FILTERS
    K872273 CORNING EASY WASH ELISA PLATES
    K872076 CORNING DISPOSABLE ROLLER BOTTLES
    K863789 CORNING ELISA PLATES
    K854024 CORNING MAGIC MAB HCG RADIOIMMUNOASSAY
    K853634 CORNING CELL WELLS-MULTIPLE WELL PLATES
    K851939 CORNING CERTAIN -ISE
    K851329 MAGIC MONOCLONAL ANTIBODY TSH(MAB TSH)RADIOIMMUNOA
    K850806 CORNING BLOOD COLLECTION CAPILLARY TUBES
    K850617 CORNING 780 FLUOROMETER/DENSITOMETER
    Search all 111 clearances from Corning Medical & Scientific →