510(k) K060480

VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL REAGENT PACK AND CALIBRATORS AND METABOLISM CONTROLS by Ortho-Clinical Diagnostics — Product Code CGR

K060480 is an FDA 510(k) premarket notification submitted by Ortho-Clinical Diagnostics for the device "VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL REAGENT PACK AND CALIBRATORS AND METABOLISM CONTROLS". The FDA issued a decision of Substantially Equivalent on July 3, 2006. The device falls under product code CGR (Radioimmunoassay, Cortisol), a Class II device regulated under 21 CFR 862.1205. Ortho-Clinical Diagnostics has at least 10 other 510(k) clearances on record.