510(k) K052525

CYBOW 11 SERIES REAGENT STRIPS FOR URINALYSIS by DFI Co., Ltd. — Product Code JIL

K052525 is an FDA 510(k) premarket notification submitted by DFI Co., Ltd. for the device "CYBOW 11 SERIES REAGENT STRIPS FOR URINALYSIS". The FDA issued a decision of Substantially Equivalent on March 29, 2006. The device falls under product code JIL (Method, Enzymatic, Glucose (Urinary, Non-Quantitative)), a Class II device regulated under 21 CFR 862.1340. DFI Co., Ltd. has at least 3 other 510(k) clearances on record.