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

    INTERLAB IMMUNOFIXATION TEST(S)

    K Number: K033187 · Decision Nov 19, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    28
    Applicant Total
    4
    Review Days
    49

    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
    INTERLAB IMMUNOFIXATION TEST(S)
    K Number
    K033187
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5510
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Interlab S.R.L.
    Date Received
    October 1, 2003
    Decision Date
    November 19, 2003
    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 Interlab S.R.L.

    K Number Device Name
    K053571 MICROGEL ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM, MICROGEL ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM
    K040146 INTERLAB ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM
    K032862 INTERLAB ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM