510(k) K993590

FRUCTOSAMINE REAGENT SET, CALIBRATOR, AND CONTROL SET by Pointe Scientific, Inc., — Product Code LCP

K993590 is an FDA 510(k) premarket notification submitted by Pointe Scientific, Inc., for the device "FRUCTOSAMINE REAGENT SET, CALIBRATOR, AND CONTROL SET". The FDA issued a decision of Substantially Equivalent on December 21, 1999. The device falls under product code LCP (Assay, Glycosylated Hemoglobin), a Class II device regulated under 21 CFR 864.7470. Pointe Scientific, Inc., has at least 10 other 510(k) clearances on record.