FDA 510(k) Applications for Medical Device Product Code "MLE"
(Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control)

FDA 510(k) Number Applicant Device Name Decision Date
K991942 COGENT DIAGNOTICS LTD. AUTOSTAT II ANTI-GPC ELISA, HY.TEC ANTI-GPC ELISA 08/24/1999
K010558 INOVA DIAGNOSTICS, INC. QUANTA LITE GPA (GASTRIC PARIETAL CELL ANTIBODY) ELISA 04/03/2001


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