510(k) K990796

AUTOSTAT II ANTI-PR 3 (C-ANCA)ELISA, HY*TEC ANTI-PR 3 (C-ANCA)ELISA by Cogent Diagnotics , Ltd. — Product Code MOB

K990796 is an FDA 510(k) premarket notification submitted by Cogent Diagnotics , Ltd. for the device "AUTOSTAT II ANTI-PR 3 (C-ANCA)ELISA, HY*TEC ANTI-PR 3 (C-ANCA)ELISA". The FDA issued a decision of Substantially Equivalent on April 28, 1999. The device falls under product code MOB (Test System, Antineutrophil Cytoplasmic Antibodies (Anca)), a Class II device regulated under 21 CFR 866.5660. Cogent Diagnotics , Ltd. has at least 10 other 510(k) clearances on record.