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

    LIAISON Vitamin B12

    K Number: K192064 · Decision Oct 2, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    77
    Applicant Total
    71
    Review Days
    62

    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 Vitamin B12
    K Number
    K192064
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1810
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    DiaSorin, Inc.
    Date Received
    August 1, 2019
    Decision Date
    October 2, 2019
    Product Code
    CDD
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    CDD Radioassay, Vitamin B12

    Similar 510(k) Clearances

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

    ARCHITECT Active-B12 (Holotranscobalamin)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Access Vitamin B12

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls Set

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM)

    FDA 510(k)
    FDA Class 2 ·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. →