Cleared Traditional

Access Thyroglobulin Antibody II

K240996 · Beckman Coulter, Inc. · Immunology
Jul 2024
Decision
83d
Days
Class 2
Risk

About This 510(k) Submission

K240996 is an FDA 510(k) clearance for the Access Thyroglobulin Antibody II, a Immunochemical, Thyroglobulin Autoantibody (Class II — Special Controls, product code JNL), submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on July 3, 2024, 83 days after receiving the submission on April 11, 2024. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5870.

Submission Details

510(k) Number K240996 FDA.gov
FDA Decision Cleared SESE
Date Received April 11, 2024
Decision Date July 03, 2024
Days to Decision 83 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code JNL — Immunochemical, Thyroglobulin Autoantibody
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5870

Similar Devices — JNL Immunochemical, Thyroglobulin Autoantibody

All 21
ADVIA Centaur Anti-Thyroglobulin II (aTgII)
K250816 · Siemens Healthcare Diagnostics, Inc. · Dec 2025
ACCESS THYROGLOBULIN ANITBODY
K112933 · Beckman Coulter, Inc. · Dec 2011
IMMUNOCAP THYRLOBULIN IMMUNOCAP
K072661 · Phadia US, Inc. · Nov 2007
ACCESS THYROGLOBULIN ANTIBODY II ASSAY, MODELS A32898 (REAGENT) AND A36920 (CALIBRATORS)
K062516 · Beckman Coulter, Inc. · Oct 2006
ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISA
K971834 · Monobind · Jul 1997
HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROGLOBULIN (TG)
K962341 · Hycor Biomedical, Inc. · Nov 1996