510(k) K900010

NDS CORTISOL TEST KIT AND NDS CORTISOL CALIBRATOR by Kallestad Diag, A Div. of Erbamont, Inc. — Product Code JFT

K900010 is an FDA 510(k) premarket notification submitted by Kallestad Diag, A Div. of Erbamont, Inc. for the device "NDS CORTISOL TEST KIT AND NDS CORTISOL CALIBRATOR". The FDA issued a decision of Substantially Equivalent on April 3, 1990. The device falls under product code JFT (Fluorometric, Cortisol), a Class II device regulated under 21 CFR 862.1205. Kallestad Diag, A Div. of Erbamont, Inc. has at least 10 other 510(k) clearances on record.