510(k) K221197

VITROS Immunodiagnostic Products Intact PTH II Reagent Pack by Ortho Clinical Diagnostics — Product Code CEW

K221197 is an FDA 510(k) premarket notification submitted by Ortho Clinical Diagnostics for the device "VITROS Immunodiagnostic Products Intact PTH II Reagent Pack". The FDA issued a decision of Substantially Equivalent on September 5, 2023. The device falls under product code CEW (Radioimmunoassay, Parathyroid Hormone), a Class II device regulated under 21 CFR 862.1545. Ortho Clinical Diagnostics has at least 10 other 510(k) clearances on record.