510(k) K230937

Alinity i Total ß-hCG Reagent Kit, GLP systems Track by Abbott Laboratories — Product Code DHA

K230937 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "Alinity i Total ß-hCG Reagent Kit, GLP systems Track". The FDA issued a decision of Substantially Equivalent on June 5, 2023. The device falls under product code DHA (System, Test, Human Chorionic Gonadotropin), a Class II device regulated under 21 CFR 862.1155. Abbott Laboratories has at least 10 other 510(k) clearances on record.