510(k) K101921

VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH REAGENT PACK, VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH CALIBRATORS, VIT by Ortho-Clinical Diagnostics — Product Code CEW

K101921 is an FDA 510(k) premarket notification submitted by Ortho-Clinical Diagnostics for the device "VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH REAGENT PACK, VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH CALIBRATORS, VIT". The FDA issued a decision of Substantially Equivalent on October 22, 2010. 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.