510(k) K133344

MINICAP HB A1C, MINICAP FLEX-PIERCING, HB A1C CAPILLARYS CONTROLS, HBA1C CAPILLARYS CALIBRATORS by Sebia — Product Code LCP

K133344 is an FDA 510(k) premarket notification submitted by Sebia for the device "MINICAP HB A1C, MINICAP FLEX-PIERCING, HB A1C CAPILLARYS CONTROLS, HBA1C CAPILLARYS CALIBRATORS". The FDA issued a decision of Substantially Equivalent on March 28, 2014. The device falls under product code LCP (Assay, Glycosylated Hemoglobin), a Class II device regulated under 21 CFR 864.7470. Sebia has at least 10 other 510(k) clearances on record.