510(k) K233581

VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack by Ortho Clinical Diagnostics — Product Code DHA

K233581 is an FDA 510(k) premarket notification submitted by Ortho Clinical Diagnostics for the device "VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack". The FDA issued a decision of Substantially Equivalent on May 8, 2024. The device falls under product code DHA (System, Test, Human Chorionic Gonadotropin), a Class II device regulated under 21 CFR 862.1155. Ortho Clinical Diagnostics has at least 10 other 510(k) clearances on record.