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

    SYNELISA TGAB/TMAB

    K Number: K915135 · Decision Apr 8, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    91
    Applicant Total
    54
    Review Days
    147

    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
    SYNELISA TGAB/TMAB
    K Number
    K915135
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5870
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Elias U.S.A., Inc.
    Date Received
    November 13, 1991
    Decision Date
    April 8, 1992
    Product Code
    JZO
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JZO System, Test, Thyroid Autoantibody

    Similar 510(k) Clearances

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

    ADVIA Centaur Anti-Thyroid Peroxidase II

    FDA 510(k)
    FDA Class 2 ·Immunology

    Access TPO Antibody

    FDA 510(k)
    FDA Class 2 ·Immunology

    Access Thyroglobulin Antibody II

    FDA 510(k)
    FDA Class 2 ·Immunology

    Elecsys Anti-Tg

    FDA 510(k)
    FDA Class 2 ·Immunology

    Elecsys Anti-TSHR

    FDA 510(k)
    FDA Class 2 ·Immunology

    EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000

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

    Other Clearances by Elias U.S.A., Inc.

    K Number Device Name
    K964385 ELIAS ANA-HEP-2
    K963291 VARELISA ANA (4) PROFILE
    K953873 VARELISA HELICOBACTER PYLORI ANTIBODIES
    K953586 VARELISA PR3-ANCA
    K953587 VARELISA MPO-ANCA
    K951187 VARELISA CARDIOLIPIN ABS SCREEN
    K951205 VARELISA ANA PROFILE
    K951206 VARELISA PARIETAL CELL ANTIBODIES
    K951207 VARELISA HISTONE ANTIBODIES
    K944334 VARELISA COMBINED DNA ANTIBODIES EIA
    Search all 54 clearances from Elias U.S.A., Inc. →