Cleared Traditional

Access Thyroglobulin

K241423 · Beckman Coulter, Inc. · Immunology
Jun 2024
Decision
18d
Days
Class 2
Risk

About This 510(k) Submission

K241423 is an FDA 510(k) clearance for the Access Thyroglobulin, a System, Test, Thyroglobulin (Class II — Special Controls, product code MSW), submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on June 7, 2024, 18 days after receiving the submission on May 20, 2024. This device falls under the Immunology review panel. Regulated under 21 CFR 866.6010.

Submission Details

510(k) Number K241423 FDA.gov
FDA Decision Cleared SESE
Date Received May 20, 2024
Decision Date June 07, 2024
Days to Decision 18 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code MSW — System, Test, Thyroglobulin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.6010

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