510(k) K811536

DIRECT TESTOSTERONE RIA by Immuchem Corp. — Product Code CDZ

K811536 is an FDA 510(k) premarket notification submitted by Immuchem Corp. for the device "DIRECT TESTOSTERONE RIA". The FDA issued a decision of Substantially Equivalent on June 18, 1981. The device falls under product code CDZ (Radioimmunoassay, Testosterones And Dihydrotestosterone), a Class I device regulated under 21 CFR 862.1680. Immuchem Corp. has at least 10 other 510(k) clearances on record.