Cleared Traditional

Atellica? IM TSH3-Ultra II (TSH3ULII)

K251543 · Siemens Healthcare Diagnostics, Inc. · Chemistry
Feb 2026
Decision
262d
Days
Class 2
Risk

About This 510(k) Submission

K251543 is an FDA 510(k) clearance for the Atellica? IM TSH3-Ultra II (TSH3ULII), a Radioimmunoassay, Thyroid-stimulating Hormone (Class II — Special Controls, product code JLW), submitted by Siemens Healthcare Diagnostics, Inc. (New York, US). The FDA issued a Cleared decision on February 6, 2026, 262 days after receiving the submission on May 20, 2025. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1690.

Submission Details

510(k) Number K251543 FDA.gov
FDA Decision Cleared SESE
Date Received May 20, 2025
Decision Date February 06, 2026
Days to Decision 262 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JLW — Radioimmunoassay, Thyroid-stimulating Hormone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1690

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