510(k) K241165

Atellica® IM High-Sensitivity Troponin I (TnIH) by Siemens Healthcare Diagnostics, Inc. — Product Code MMI

K241165 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics, Inc. for the device "Atellica® IM High-Sensitivity Troponin I (TnIH)". The FDA issued a decision of Substantially Equivalent on July 25, 2024. The device falls under product code MMI (Immunoassay Method, Troponin Subunit), a Class II device regulated under 21 CFR 862.1215. Siemens Healthcare Diagnostics, Inc. has at least 10 other 510(k) clearances on record.