K251543

Substantially Equivalent

Atellica® IM TSH3-Ultra II (TSH3ULII)

Applicant: Siemens Healthcare Diagnostics, Inc.
Product code: JLW
Advisory panel: Clinical Chemistry
Date received: 2025-05-20
Decision date: 2026-02-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

Adverse events under product code JLW

product code JLW

Malfunction: 885
Total: 885

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.