510(k) K022356

NICHOLS ADVANTAGE CHEMILUMINESCENCE HELICOBACTOR PYLORI IGG ANTIBODIES IMMUNOASSAY by Nichols Institute Diagnostics — Product Code LYR

K022356 is an FDA 510(k) premarket notification submitted by Nichols Institute Diagnostics for the device "NICHOLS ADVANTAGE CHEMILUMINESCENCE HELICOBACTOR PYLORI IGG ANTIBODIES IMMUNOASSAY". The FDA issued a decision of Substantially Equivalent on October 25, 2002. The device falls under product code LYR (Helicobacter Pylori), a Class I device regulated under 21 CFR 866.3110. Nichols Institute Diagnostics has at least 10 other 510(k) clearances on record.