510(k) K852986

GLYCO-SEP/ALC TEST KIT FOR SEPARAT OF HEMOGLOBIN by Clinical Technology Corp. — Product Code LCP

K852986 is an FDA 510(k) premarket notification submitted by Clinical Technology Corp. for the device "GLYCO-SEP/ALC TEST KIT FOR SEPARAT OF HEMOGLOBIN". The FDA issued a decision of Substantially Equivalent on August 19, 1985. The device falls under product code LCP (Assay, Glycosylated Hemoglobin), a Class II device regulated under 21 CFR 864.7470. Clinical Technology Corp. has at least 10 other 510(k) clearances on record.