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

    LIAISON VZV IgG HT, LIAISON Control VZV IgG HT

    K Number: K231214 · Decision Oct 27, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    16
    Applicant Total
    71
    Review Days
    182

    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 VZV IgG HT, LIAISON Control VZV IgG HT
    K Number
    K231214
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3900
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    DiaSorin, Inc.
    Date Received
    April 28, 2023
    Decision Date
    October 27, 2023
    Product Code
    LFY
    Advisory Committee
    Microbiology
    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
    LFY Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster

    Similar 510(k) Clearances

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

    LIAISON VZV IgG, LIAISON Control VZV IgG

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ZEUS SCIENTIFIC, INC VZV IGM ELISA TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    DIASORIN LIAISON VZV IGG

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MMRV IGG TEST SYSTEM.

    FDA 510(k)
    FDA Class 2 ·Microbiology

    THE APTUS (AUTOMATED) APPLICATION OF THE VZV IGG ELISA TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    IS-VZU IGG TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Microbiology
    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)
    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
    K201908 LIAISON Testosterone xt
    Search all 71 clearances from DiaSorin, Inc. →