510(k) K052649

DRG SLV TESTOSTERONE ELISA TEST by Drg Intl., Inc. — Product Code CDZ

K052649 is an FDA 510(k) premarket notification submitted by Drg Intl., Inc. for the device "DRG SLV TESTOSTERONE ELISA TEST". The FDA issued a decision of Substantially Equivalent on January 27, 2006. The device falls under product code CDZ (Radioimmunoassay, Testosterones And Dihydrotestosterone), a Class I device regulated under 21 CFR 862.1680. Drg Intl., Inc. has at least 3 other 510(k) clearances on record.