510(k) K201312

VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack by Ortho Clinical Diagnostics — Product Code NBC

K201312 is an FDA 510(k) premarket notification submitted by Ortho Clinical Diagnostics for the device "VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack". The FDA issued a decision of Substantially Equivalent on October 4, 2021. The device falls under product code NBC (Test, Natriuretic Peptide), a Class II device regulated under 21 CFR 862.1117. Ortho Clinical Diagnostics has at least 10 other 510(k) clearances on record.