510(k) K230994

Alinity i STAT High Sensitivity Troponin-I by Abbott Laboratories Diagnostics Division — Product Code MMI

K230994 is an FDA 510(k) premarket notification submitted by Abbott Laboratories Diagnostics Division for the device "Alinity i STAT High Sensitivity Troponin-I". The FDA issued a decision of Substantially Equivalent on May 4, 2023. The device falls under product code MMI (Immunoassay Method, Troponin Subunit), a Class II device regulated under 21 CFR 862.1215. Abbott Laboratories Diagnostics Division has at least 3 other 510(k) clearances on record.