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

    PHARMACIA CMV IGM ELISA

    K Number: K921011 · Decision Jul 27, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    57
    Applicant Total
    7
    Review Days
    146

    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
    PHARMACIA CMV IGM ELISA
    K Number
    K921011
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3175
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Pharmacia Diagnostics, Inc.
    Date Received
    March 3, 1992
    Decision Date
    July 27, 1992
    Product Code
    LFZ
    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
    LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus

    Similar 510(k) Clearances

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

    Architect CMV IgG

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Elecsys CMV IgG

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Elecsys CMV IgM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control Set

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ELECYS CMV IGM IMMUNOASSAY; ELECYS PRECICONTROL CMV IGM

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

    Other Clearances by Pharmacia Diagnostics, Inc.

    K Number Device Name
    K920702 TOXOPLASMA GONDII (TOXO) IGM ENZYME-LINKED IMMUNO
    K915348 EBV-VCA IGM ELISA
    K914022 SERIOLOGICAL TEST KIT/IGM ANTIBODY VARI-ZOST VIRUS
    K912026 DELFIA(R) 17 -OH-PROGESTERON KIT
    K902793 RUBELLA IGG
    K902792 TOXOPLASMA GONDII IGG