510(k) K782110

RIA KIT, RIANEN CORTISOL by New England Nuclear — Product Code CGR

K782110 is an FDA 510(k) premarket notification submitted by New England Nuclear for the device "RIA KIT, RIANEN CORTISOL". The FDA issued a decision of Substantially Equivalent on January 26, 1979. The device falls under product code CGR (Radioimmunoassay, Cortisol), a Class II device regulated under 21 CFR 862.1205. New England Nuclear has at least 10 other 510(k) clearances on record.