510(k) K060585

ROCHE ELECSYS- ACTH,ACTH CALSET,ACTH CALCHECK,PRECICONTROL ACTH by Roche Diagnostics Corp. — Product Code CKG

K060585 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Corp. for the device "ROCHE ELECSYS- ACTH,ACTH CALSET,ACTH CALCHECK,PRECICONTROL ACTH". The FDA issued a decision of Substantially Equivalent on May 3, 2006. The device falls under product code CKG (Radioimmunoassay, Acth), a Class II device regulated under 21 CFR 862.1025. Roche Diagnostics Corp. has at least 10 other 510(k) clearances on record.