510(k) K761346

RADIOIMMUNOASSAY KIT(CORTISOL IN PLASMA) by New England Nuclear — Product Code CGR

K761346 is an FDA 510(k) premarket notification submitted by New England Nuclear for the device "RADIOIMMUNOASSAY KIT(CORTISOL IN PLASMA)". The FDA issued a decision of Substantially Equivalent on January 7, 1977. 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.