510(k) K872852

EAGLE DIAGNOSTICS GLYCOHEMOGLOBIN UNITIZED TEST by Sandare Chemical Co., Inc. — Product Code LCP

K872852 is an FDA 510(k) premarket notification submitted by Sandare Chemical Co., Inc. for the device "EAGLE DIAGNOSTICS GLYCOHEMOGLOBIN UNITIZED TEST". The FDA issued a decision of Substantially Equivalent on September 29, 1987. The device falls under product code LCP (Assay, Glycosylated Hemoglobin), a Class II device regulated under 21 CFR 864.7470. Sandare Chemical Co., Inc. has at least 10 other 510(k) clearances on record.