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

    LIAISON EBV IgM Serum Control Set

    K Number: K161522 · Decision Jun 30, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    269
    Registration Numbers
    269
    Same Product Code
    492
    Applicant Total
    71
    Review Days
    28

    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
    LIAISON EBV IgM Serum Control Set
    K Number
    K161522
    Device Class
    FDA class 1
    Clearance Type
    Special
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    DiaSorin, Inc.
    Date Received
    June 2, 2016
    Decision Date
    June 30, 2016
    Product Code
    JJX
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JJX Single (Specified) Analyte Controls (Assayed And Unassayed)

    Similar 510(k) Clearances

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

    Beta-CrossLaps CalCheck 5

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Elecsys CYFRA 21-1 CalCheck 5

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Multichem A1c

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Audit MicroControls Linearity DROP LQ Blood Glucose

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    LIAISON CMV IgM Serum Control Set

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration Verifiers

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry
    View all

    Other Clearances by DiaSorin, Inc.

    K Number Device Name
    K260770 LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX
    DEN250032 LIAISON® XL MUREX Anti-HDV (318260); LIAISON® XL MUREX Control Anti-HDV (318261)
    K231214 LIAISON VZV IgG HT, LIAISON Control VZV IgG HT
    K223403 LIAISON Anti-HAV; LIAISON XS
    K213858 LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus
    K213936 LIAISON MeMed BV, LIAISON MeMed BV Control Set
    K193650 LIAISON Ferritin
    K202573 LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody Plus
    K202574 LIAISON Lyme IgG, LIAISON Lyme IgG Control Set, LIAISON Lyme Total Antibody Plus
    K210272 LIAISON Anti-HAV
    Search all 71 clearances from DiaSorin, Inc. →