510(k) K082227

MINICAP HEMOGLOBIN(E) KIT, MODEL 2207, 2227 by Sebia — Product Code GKA

K082227 is an FDA 510(k) premarket notification submitted by Sebia for the device "MINICAP HEMOGLOBIN(E) KIT, MODEL 2207, 2227". The FDA issued a decision of Substantially Equivalent on March 26, 2009. The device falls under product code GKA (Abnormal Hemoglobin Quantitation), a Class II device regulated under 21 CFR 864.7415. Sebia has at least 10 other 510(k) clearances on record.