510(k) K991890

AUTOSTAT II ANTI-GBM ELISA, HY.TEC ANTI-GMB ELISA by Cogent Diagnotics , Ltd. — Product Code MVJ

K991890 is an FDA 510(k) premarket notification submitted by Cogent Diagnotics , Ltd. for the device "AUTOSTAT II ANTI-GBM ELISA, HY.TEC ANTI-GMB ELISA". The FDA issued a decision of Substantially Equivalent on August 9, 1999. 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. Cogent Diagnotics , Ltd. has at least 10 other 510(k) clearances on record.