510(k) K163418

Diazyme DZ-Lite Total beta-hCG Test System by Diazyme Laboratories — Product Code DHA

K163418 is an FDA 510(k) premarket notification submitted by Diazyme Laboratories for the device "Diazyme DZ-Lite Total beta-hCG Test System". The FDA issued a decision of Substantially Equivalent on August 18, 2017. The device falls under product code DHA (System, Test, Human Chorionic Gonadotropin), a Class II device regulated under 21 CFR 862.1155. Diazyme Laboratories has at least 10 other 510(k) clearances on record.