510(k) K982680

CHIRON DIAGNOSTICS CORPORATION ACS: CENTAUR BR IMMUNOASSAY by Chiron Diagnostics Corp. — Product Code MOI

K982680 is an FDA 510(k) premarket notification submitted by Chiron Diagnostics Corp. for the device "CHIRON DIAGNOSTICS CORPORATION ACS: CENTAUR BR IMMUNOASSAY". The FDA issued a decision of Substantially Equivalent on October 15, 1998. The device falls under product code MOI (System, Test, Immunological, Antigen, Tumor), a Class II device regulated under 21 CFR 866.6010. Chiron Diagnostics Corp. has at least 10 other 510(k) clearances on record.