Cleared Traditional

Access TPO Antibody

K240469 · Beckman Coulter, Inc. · Immunology
Aug 2024
Decision
171d
Days
Class 2
Risk

About This 510(k) Submission

K240469 is an FDA 510(k) clearance for the Access TPO Antibody, 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 August 9, 2024, 171 days after receiving the submission on February 20, 2024. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5870.

Submission Details

510(k) Number K240469 FDA.gov
FDA Decision Cleared SESE
Date Received February 20, 2024
Decision Date August 09, 2024
Days to Decision 171 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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