510(k) K992188

NICHOLS ADVANTAGE CHEMILUMINESCENCE SOLUBLE TRANSFERRIN RECEPTOR IMMUNOASSAY, MODEL 62-7028 by Nichols Institute Diagnostics — Product Code JNM

K992188 is an FDA 510(k) premarket notification submitted by Nichols Institute Diagnostics for the device "NICHOLS ADVANTAGE CHEMILUMINESCENCE SOLUBLE TRANSFERRIN RECEPTOR IMMUNOASSAY, MODEL 62-7028". The FDA issued a decision of Substantially Equivalent on December 6, 1999. The device falls under product code JNM (Immunochemical, Transferrin), a Class II device regulated under 21 CFR 866.5880. Nichols Institute Diagnostics has at least 10 other 510(k) clearances on record.