510(k) K893894

CHARISE CHARLES REAGENT BLOOD STRIPS by Lee Import Domestic Consulting — Product Code JIO

K893894 is an FDA 510(k) premarket notification submitted by Lee Import Domestic Consulting for the device "CHARISE CHARLES REAGENT BLOOD STRIPS". The FDA issued a decision of Substantially Equivalent on July 27, 1989. The device falls under product code JIO (Blood, Occult, Colorimetric, In Urine), a Class II device regulated under 21 CFR 864.6550. Lee Import Domestic Consulting has at least 1 other 510(k) clearance on record.