DeviceClearance

Atellica® IM TSH3-Ultra II (TSH3ULII)— 510(k) K251543

Substantially Equivalent

Siemens Healthcare Diagnostics, Inc.

FDA 510(k) clearance K251543 for Atellica® IM TSH3-Ultra II (TSH3ULII), Substantially Equivalent on 2026-02-06. Applicant: Siemens Healthcare Diagnostics, Inc.. Device class: 2.

Summary

Siemens Healthcare Diagnostics' Atellica® IM TSH3-Ultra II (TSH3ULII) is filed under product code JLW (Radioimmunoassay, Thyroid-Stimulating Hormone). The record doesn't describe the device beyond its name and that code name.

Class II, 21 CFR 862.1690. Clinical Chemistry is both the classification panel and the review panel, and it came in as a Traditional 510(k).

Siemens Healthcare Diagnostics filed from Tarrytown, New York. The substantially equivalent decision came 262 calendar days after receipt (May 20, 2025 to February 6, 2026).

Clearance details

Applicant
Siemens Healthcare Diagnostics, Inc.
Product code
Product code JLW
Device class
Class 2
Regulation
21 CFR 862.1690
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Tarrytown, NY, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code JLW

product code JLW
Malfunction
885
Total
885

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.