510(k) K010558

QUANTA LITE GPA (GASTRIC PARIETAL CELL ANTIBODY) ELISA by Inova Diagnostics, Inc. — Product Code MLE

K010558 is an FDA 510(k) premarket notification submitted by Inova Diagnostics, Inc. for the device "QUANTA LITE GPA (GASTRIC PARIETAL CELL ANTIBODY) ELISA". The FDA issued a decision of Substantially Equivalent on April 3, 2001. The device falls under product code MLE (Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control), a Class II device regulated under 21 CFR 866.5110. Inova Diagnostics, Inc. has at least 10 other 510(k) clearances on record.