510(k) K932951

DELFIA TESTTOSTERONE KIT by Wallac OY — Product Code CDZ

K932951 is an FDA 510(k) premarket notification submitted by Wallac OY for the device "DELFIA TESTTOSTERONE KIT". The FDA issued a decision of Substantially Equivalent on August 3, 1993. The device falls under product code CDZ (Radioimmunoassay, Testosterones And Dihydrotestosterone), a Class I device regulated under 21 CFR 862.1680. Wallac OY has at least 10 other 510(k) clearances on record.