510(k) K024360

INSTANT-VIEW H. PYLORI ONE STEP RAPID TEST by Alfa Scientific Designs, Inc. — Product Code LYR

K024360 is an FDA 510(k) premarket notification submitted by Alfa Scientific Designs, Inc. for the device "INSTANT-VIEW H. PYLORI ONE STEP RAPID TEST". The FDA issued a decision of Substantially Equivalent on June 10, 2003. The device falls under product code LYR (Helicobacter Pylori), a Class I device regulated under 21 CFR 866.3110. Alfa Scientific Designs, Inc. has at least 10 other 510(k) clearances on record.