510(k) K011348

PHASE II GBM IGG ANTIBODY EIA TEST by Scimedx Corp. — Product Code MVJ

K011348 is an FDA 510(k) premarket notification submitted by Scimedx Corp. for the device "PHASE II GBM IGG ANTIBODY EIA TEST". The FDA issued a decision of Substantially Equivalent on June 25, 2001. The device falls under product code MVJ (Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)), a Class II device regulated under 21 CFR 866.5660. Scimedx Corp. has at least 10 other 510(k) clearances on record.