FDA 510(k) Applications for Medical Device Product Code "NRI"
(Autoantibodies, Nuclear Pore Glycoprotein Gp210)

FDA 510(k) Number Applicant Device Name Decision Date
K040885 INOVA DIAGNOSTICS, INC. QUANTA LITE GP210 ELISA 06/25/2004
K061842 INOVA DIAGNOSTICS, INC. QUANTA LITE PBC SCREEN IGG/IGA ELISA 10/18/2006


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact