510(k) K060818

ARCHITECT SHBG REAGENT KIT, ARCHITECT SHBG CALIBRATOR KIT, AND ARCHITECT SHBG CONTROL KIT WITH MODELS, 8K26-25, 8K26-01 by Biokit, S.A. — Product Code CDZ

K060818 is an FDA 510(k) premarket notification submitted by Biokit, S.A. for the device "ARCHITECT SHBG REAGENT KIT, ARCHITECT SHBG CALIBRATOR KIT, AND ARCHITECT SHBG CONTROL KIT WITH MODELS, 8K26-25, 8K26-01". The FDA issued a decision of Substantially Equivalent on January 23, 2007. The device falls under product code CDZ (Radioimmunoassay, Testosterones And Dihydrotestosterone), a Class I device regulated under 21 CFR 862.1680. Biokit, S.A. has at least 10 other 510(k) clearances on record.