510(k) K201908

LIAISON Testosterone xt by DiaSorin, Inc. — Product Code CDZ

K201908 is an FDA 510(k) premarket notification submitted by DiaSorin, Inc. for the device "LIAISON Testosterone xt". The FDA issued a decision of Substantially Equivalent on October 15, 2020. The device falls under product code CDZ (Radioimmunoassay, Testosterones And Dihydrotestosterone), a Class I device regulated under 21 CFR 862.1680. DiaSorin, Inc. has at least 10 other 510(k) clearances on record.