Atellica® IM TSH3-Ultra II (TSH3ULII)

Atellica® IM TSH3-Ultra II (TSH3ULII) is an FDA 510(k)-cleared medical device (K251543) manufactured by Siemens Healthcare Diagnostics, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 5, 2026. Regulation: 8.