510(k) K203227

Elecsys HCG STAT by Roche Diagnostics — Product Code DHA

K203227 is an FDA 510(k) premarket notification submitted by Roche Diagnostics for the device "Elecsys HCG STAT". The FDA issued a decision of Substantially Equivalent on August 18, 2021. The device falls under product code DHA (System, Test, Human Chorionic Gonadotropin), a Class II device regulated under 21 CFR 862.1155. Roche Diagnostics has at least 10 other 510(k) clearances on record.