510(k) K834294

ELTRACHEM DIATRAC GLYCOSYLATED HEMOGLOB by Emd Chemicals, Inc. — Product Code LCP

K834294 is an FDA 510(k) premarket notification submitted by Emd Chemicals, Inc. for the device "ELTRACHEM DIATRAC GLYCOSYLATED HEMOGLOB". The FDA issued a decision of Substantially Equivalent on January 24, 1984. The device falls under product code LCP (Assay, Glycosylated Hemoglobin), a Class II device regulated under 21 CFR 864.7470. Emd Chemicals, Inc. has at least 10 other 510(k) clearances on record.