510(k) K800538

GAMMA STICK CORTISOL RIA KIT/STICK KIT by Alpha Gamma Laboratory — Product Code CGR

K800538 is an FDA 510(k) premarket notification submitted by Alpha Gamma Laboratory for the device "GAMMA STICK CORTISOL RIA KIT/STICK KIT". The FDA issued a decision of Substantially Equivalent on April 24, 1980. The device falls under product code CGR (Radioimmunoassay, Cortisol), a Class II device regulated under 21 CFR 862.1205. Alpha Gamma Laboratory has at least 3 other 510(k) clearances on record.