Cleared Traditional

Access Thyroglobulin Antibody II

K213517 · Beckman Coulter, Inc. · Immunology
Sep 2023
Decision
692d
Days
Class 2
Risk

About This 510(k) Submission

K213517 is an FDA 510(k) clearance for the Access Thyroglobulin Antibody II, a System, Test, Thyroid Autoantibody (Class II — Special Controls, product code JZO), submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on September 26, 2023, 692 days after receiving the submission on November 3, 2021. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5870.

Submission Details

510(k) Number K213517 FDA.gov
FDA Decision Cleared SESE
Date Received November 03, 2021
Decision Date September 26, 2023
Days to Decision 692 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code JZO — System, Test, Thyroid Autoantibody
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5870

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