510(k) K063295

ACON UTI URINARY TRACT INFECTION TEST STRIPS by ACON Laboratories, Inc. — Product Code LJX

K063295 is an FDA 510(k) premarket notification submitted by ACON Laboratories, Inc. for the device "ACON UTI URINARY TRACT INFECTION TEST STRIPS". The FDA issued a decision of Substantially Equivalent on October 12, 2007. The device falls under product code LJX (Test, Urine Leukocyte), a Class I device regulated under 21 CFR 864.7675. ACON Laboratories, Inc. has at least 10 other 510(k) clearances on record.