510(k) K222116

Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP) by Siemens Healthcare Diagnostics, Inc. — Product Code JLW

K222116 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics, Inc. for the device "Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP)". The FDA issued a decision of Substantially Equivalent on July 13, 2023. The device falls under product code JLW (Radioimmunoassay, Thyroid-Stimulating Hormone), a Class II device regulated under 21 CFR 862.1690. Siemens Healthcare Diagnostics, Inc. has at least 10 other 510(k) clearances on record.