510(k) K934317

CIDBA CORNING ACS CORTISOL IMMUNOASSAY by Ciba Corning Diagnostics Corp. — Product Code JFT

K934317 is an FDA 510(k) premarket notification submitted by Ciba Corning Diagnostics Corp. for the device "CIDBA CORNING ACS CORTISOL IMMUNOASSAY". The FDA issued a decision of Substantially Equivalent on May 13, 1994. The device falls under product code JFT (Fluorometric, Cortisol), a Class II device regulated under 21 CFR 862.1205. Ciba Corning Diagnostics Corp. has at least 10 other 510(k) clearances on record.