510(k) K211685

Elecsys Testosterone II by Roche Diagnostics — Product Code CDZ

K211685 is an FDA 510(k) premarket notification submitted by Roche Diagnostics for the device "Elecsys Testosterone II". The FDA issued a decision of Substantially Equivalent on May 6, 2022. The device falls under product code CDZ (Radioimmunoassay, Testosterones And Dihydrotestosterone), a Class I device regulated under 21 CFR 862.1680. Roche Diagnostics has at least 10 other 510(k) clearances on record.