510(k) K212221

Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer by Diazyme Laboratories, Inc. — Product Code DHA

K212221 is an FDA 510(k) premarket notification submitted by Diazyme Laboratories, Inc. for the device "Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer". The FDA issued a decision of Substantially Equivalent on December 13, 2021. The device falls under product code DHA (System, Test, Human Chorionic Gonadotropin), a Class II device regulated under 21 CFR 862.1155. Diazyme Laboratories, Inc. has at least 10 other 510(k) clearances on record.