510(k) K841948

TESTOSTERONE DIRECT RADIOIMMUNOASSAY by Sorin Biomedica, Fiat, USA, Inc. — Product Code CDZ

K841948 is an FDA 510(k) premarket notification submitted by Sorin Biomedica, Fiat, USA, Inc. for the device "TESTOSTERONE DIRECT RADIOIMMUNOASSAY". The FDA issued a decision of Substantially Equivalent on June 25, 1984. The device falls under product code CDZ (Radioimmunoassay, Testosterones And Dihydrotestosterone), a Class I device regulated under 21 CFR 862.1680. Sorin Biomedica, Fiat, USA, Inc. has at least 10 other 510(k) clearances on record.