510(k) K984186

NICHOLS ADVANTAGE CHEMILUMINESCENCE FERRITIN IMMUNOASSAY by Nichols Institute Diagnostics — Product Code DBF

K984186 is an FDA 510(k) premarket notification submitted by Nichols Institute Diagnostics for the device "NICHOLS ADVANTAGE CHEMILUMINESCENCE FERRITIN IMMUNOASSAY". The FDA issued a decision of Substantially Equivalent on February 2, 1999. The device falls under product code DBF (Ferritin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5340. Nichols Institute Diagnostics has at least 10 other 510(k) clearances on record.