Cleared Traditional

Atellica IM Thyroglobulin (Tg)

K242981 · Siemens Healthcare Diagnostics, Inc. · Immunology
Jun 2025
Decision
267d
Days
Class 2
Risk

About This 510(k) Submission

K242981 is an FDA 510(k) clearance for the Atellica IM Thyroglobulin (Tg), a System, Test, Thyroglobulin (Class II — Special Controls, product code MSW), submitted by Siemens Healthcare Diagnostics, Inc. (New York, US). The FDA issued a Cleared decision on June 20, 2025, 267 days after receiving the submission on September 26, 2024. This device falls under the Immunology review panel. Regulated under 21 CFR 866.6010.

Submission Details

510(k) Number K242981 FDA.gov
FDA Decision Cleared SESE
Date Received September 26, 2024
Decision Date June 20, 2025
Days to Decision 267 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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