510(k) K053571

MICROGEL ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM, MICROGEL ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM by Interlab S.R.L. — Product Code JBD

K053571 is an FDA 510(k) premarket notification submitted by Interlab S.R.L. for the device "MICROGEL ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM, MICROGEL ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on June 30, 2006. The device falls under product code JBD (System, Analysis, Electrophoretic Hemoglobin), a Class II device regulated under 21 CFR 864.7440. Interlab S.R.L. has at least 3 other 510(k) clearances on record.