510(k) K063306

ACE HEMOGLOBIN A1C REAGENT, MODEL ACI-21, HEMOGLOBIN A1C CALIBRATORS, MODEL S2-72, HEMOGLOBIN A1C CONTROLS, MODEL C2-72 by Alfa Wassermann, Inc. — Product Code LCP

K063306 is an FDA 510(k) premarket notification submitted by Alfa Wassermann, Inc. for the device "ACE HEMOGLOBIN A1C REAGENT, MODEL ACI-21, HEMOGLOBIN A1C CALIBRATORS, MODEL S2-72, HEMOGLOBIN A1C CONTROLS, MODEL C2-72". The FDA issued a decision of Substantially Equivalent on April 17, 2007. The device falls under product code LCP (Assay, Glycosylated Hemoglobin), a Class II device regulated under 21 CFR 864.7470. Alfa Wassermann, Inc. has at least 8 other 510(k) clearances on record.