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

    SYNELISA TPO ANTIBODIES

    K Number: K921787 · Decision Jul 28, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    20
    Applicant Total
    45
    Review Days
    105

    Basic Information

    Device Name
    SYNELISA TPO ANTIBODIES
    K Number
    K921787
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5870
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    ELIAS USA, INC.
    Date Received
    April 14, 1992
    Decision Date
    July 28, 1992
    Product Code
    JNL
    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
    JNL Immunochemical, Thyroglobulin Autoantibody

    Similar 510(k) Clearances

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

    Access Thyroglobulin Antibody II

    FDA 510(k)
    FDA Class 2 ·Immunology

    ACCESS THYROGLOBULIN ANITBODY

    FDA 510(k)
    FDA Class 2 ·Immunology

    IMMUNOCAP THYRLOBULIN IMMUNOCAP

    FDA 510(k)
    FDA Class 2 ·Immunology

    ACCESS THYROGLOBULIN ANTIBODY II ASSAY, MODELS A32898 (REAGENT) AND A36920 (CALIBRATORS)

    FDA 510(k)
    FDA Class 2 ·Immunology

    ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISA

    FDA 510(k)
    FDA Class 2 ·Immunology

    HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROID MICROSOMAL (TPO)

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

    Other Clearances by ELIAS USA, INC.

    K Number Device Name
    K964385 ELIAS ANA-HEP-2
    K963291 VARELISA ANA (4) PROFILE
    K953873 VARELISA HELICOBACTER PYLORI ANTIBODIES
    K951187 VARELISA CARDIOLIPIN ABS SCREEN
    K951206 VARELISA PARIETAL CELL ANTIBODIES
    K951205 VARELISA ANA PROFILE
    K951207 VARELISA HISTONE ANTIBODIES
    K944334 VARELISA COMBINED DNA ANTIBODIES EIA
    K951186 VARELISA ANA-4 SCREEN
    K950031 VARELISA DSDNA ANTIBODIES (FARR VERSION)
    Search all 45 clearances from ELIAS USA, INC. →