510(k) K971418

CHIRON DIAGNOSTICS AUTOMATED CHEMILUMINESCENCE SYSTEM (ASC) CENTAUR ANALYZER by Chiron Diagnostics Corp. — Product Code MOI

K971418 is an FDA 510(k) premarket notification submitted by Chiron Diagnostics Corp. for the device "CHIRON DIAGNOSTICS AUTOMATED CHEMILUMINESCENCE SYSTEM (ASC) CENTAUR ANALYZER". The FDA issued a decision of Substantially Equivalent on July 17, 1997. 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.