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

    IMMUNOCAP THYRLOBULIN IMMUNOCAP

    K Number: K072661 · Decision Nov 20, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    21
    Applicant Total
    22
    Review Days
    60

    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
    IMMUNOCAP THYRLOBULIN IMMUNOCAP
    K Number
    K072661
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    866.5870
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Phadia US, Inc.
    Date Received
    September 21, 2007
    Decision Date
    November 20, 2007
    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.

    ADVIA Centaur Anti-Thyroglobulin II (aTgII)

    FDA 510(k)
    FDA Class 2 ·Immunology

    Access Thyroglobulin Antibody II

    FDA 510(k)
    FDA Class 2 ·Immunology

    ACCESS THYROGLOBULIN ANITBODY

    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 Phadia US, Inc.

    K Number Device Name
    K141375 ELIA M2; IMMUNOASSAY, POSITIVE CONTROL 100, POSITIVE CONTROL 250
    K140225 ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM PO
    K132631 EIA SMDP IMMUNOASSAY
    K131821 ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAY
    K122197 AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES
    K113841 IMMUNOCAP ALLERGEN COMPONENTS BUNDLE
    K112414 ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY
    DEN120001 IMMUNOCAP TRYPTASE, CALIBRATORS, CURVE CONTROL, CONJUGATE 50, CALIBRATOR STRIP, CURVE CONTROL STRIP, ANTI-TRYPTASE
    K111919 IMMUNOCAP SPECIFIC IGE ALLERGEN BUNDLE, 12 ALLERGEN COMPONENTS
    K102673 RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM
    Search all 22 clearances from Phadia US, Inc. →