510(k) K181024

DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips by DFI Co., Ltd. — Product Code JIL

K181024 is an FDA 510(k) premarket notification submitted by DFI Co., Ltd. for the device "DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips". The FDA issued a decision of Substantially Equivalent on May 23, 2018. 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.