510(k) K000239

GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL by Genzyme Corp. — Product Code LCP

K000239 is an FDA 510(k) premarket notification submitted by Genzyme Corp. for the device "GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL". The FDA issued a decision of Substantially Equivalent on March 21, 2000. The device falls under product code LCP (Assay, Glycosylated Hemoglobin), a Class II device regulated under 21 CFR 864.7470. Genzyme Corp. has at least 10 other 510(k) clearances on record.