510(k) K103627

ARCHITECT ICARBAMAZEPINE ICARBAMAZEPINE REAGENTS; ARCHITECT ICARBAMAZEPINE CALIBRATORS by Abbott Laboratories — Product Code KLT

K103627 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "ARCHITECT ICARBAMAZEPINE ICARBAMAZEPINE REAGENTS; ARCHITECT ICARBAMAZEPINE CALIBRATORS". The FDA issued a decision of Substantially Equivalent on October 14, 2011. The device falls under product code KLT (Enzyme Immunoassay, Carbamazepine), a Class II device regulated under 21 CFR 862.3645. Abbott Laboratories has at least 10 other 510(k) clearances on record.