510(k) K033674

MULTIGENT HEMOGLOBIN A1C (REAGENTS), HB A1C CALIBRATORS AND HB A1C CONTROLS by Seradyn, Inc. — Product Code LCP

K033674 is an FDA 510(k) premarket notification submitted by Seradyn, Inc. for the device "MULTIGENT HEMOGLOBIN A1C (REAGENTS), HB A1C CALIBRATORS AND HB A1C CONTROLS". The FDA issued a decision of Substantially Equivalent on February 9, 2004. The device falls under product code LCP (Assay, Glycosylated Hemoglobin), a Class II device regulated under 21 CFR 864.7470. Seradyn, Inc. has at least 10 other 510(k) clearances on record.