510(k) K152155

ARCHITECT 2nd Generation Testosterone by Abbott Laboratories — Product Code CDZ

K152155 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "ARCHITECT 2nd Generation Testosterone". The FDA issued a decision of Substantially Equivalent on December 17, 2015. The device falls under product code CDZ (Radioimmunoassay, Testosterones And Dihydrotestosterone), a Class I device regulated under 21 CFR 862.1680. Abbott Laboratories has at least 10 other 510(k) clearances on record.