510(k) K780792

TESTOSTERONE RADIOIMMUNOASSAY KIT 125I by The Upjohn Co. — Product Code CDZ

K780792 is an FDA 510(k) premarket notification submitted by The Upjohn Co. for the device "TESTOSTERONE RADIOIMMUNOASSAY KIT 125I". The FDA issued a decision of Substantially Equivalent on June 13, 1978. The device falls under product code CDZ (Radioimmunoassay, Testosterones And Dihydrotestosterone), a Class I device regulated under 21 CFR 862.1680. The Upjohn Co. has at least 5 other 510(k) clearances on record.