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

    TOXOPLASMA GONDII ANTIBODY IGG

    K Number: K822605 · Decision Oct 27, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    5
    Applicant Total
    15
    Review Days
    61

    Basic Information

    Device Name
    TOXOPLASMA GONDII ANTIBODY IGG
    K Number
    K822605
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3780
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    IMMULOK, INC.
    Date Received
    August 27, 1982
    Decision Date
    October 27, 1982
    Product Code
    LJK
    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
    LJK Antisera, If, Toxoplasma Gondii

    Similar 510(k) Clearances

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

    ACCURUN 135 TOXOPLASMA IGG POSITIVE CONTROL

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ARD(TM) ANTIMICROBIAL REMOVAL DEVICE

    FDA 510(k)
    FDA Class 2 ·Microbiology

    THE GOLDEN QUAD TEST (TOXO)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    SOLID STATE CONTINUOUS FLOW CONTROL MODEL W/K101

    FDA 510(k)
    FDA Class 2 ·Microbiology

    TOXO IPA KIT IAN INDIRECT FLUORESCENT

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

    Other Clearances by IMMULOK, INC.

    K Number Device Name
    K830971 HERPES SIMPLEX VIRUS TYPING REAGENTS
    K830342 CULUTURE SET CHLAMYDIA ISOLATION AND
    K830250 CVT VIRAL TRANSPORTS
    K823304 RIASET PROLACTIN RIA KIT
    K822785 FLUOROSET IMMUNOFLUORESCENT ANTIBODY
    K823055 FLOUROSET IMMUNOFLUORESCENT ANTIBODY
    K822606 CYTOMEGALOVIRUS ANTOBODY IGG
    K822607 ANTINUCLEAR ANTOBODY CELL SUBSTRATE
    K821567 IMMULOK CULTURESET
    K821411 HISTOSET IMMUNOPEROFIDASE TISSUE
    Search all 15 clearances from IMMULOK, INC. →