510(k) K984520

NICHOLS ADVANTAGE CHEMILUMINESCENCE CORTISOL IMMUNOASSAY, MODEL 62-7005 by Nichols Institute Diagnostics — Product Code CGR

K984520 is an FDA 510(k) premarket notification submitted by Nichols Institute Diagnostics for the device "NICHOLS ADVANTAGE CHEMILUMINESCENCE CORTISOL IMMUNOASSAY, MODEL 62-7005". The FDA issued a decision of Substantially Equivalent on February 5, 1999. The device falls under product code CGR (Radioimmunoassay, Cortisol), a Class II device regulated under 21 CFR 862.1205. Nichols Institute Diagnostics has at least 10 other 510(k) clearances on record.