510(k) K983990

VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL ASSAY by Ortho-Clinical Diagnostics, Inc. — Product Code CGR

K983990 is an FDA 510(k) premarket notification submitted by Ortho-Clinical Diagnostics, Inc. for the device "VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL ASSAY". The FDA issued a decision of Substantially Equivalent on December 29, 1998. The device falls under product code CGR (Radioimmunoassay, Cortisol), a Class II device regulated under 21 CFR 862.1205. Ortho-Clinical Diagnostics, Inc. has at least 10 other 510(k) clearances on record.