510(k) K122101

CAPILLARYS HEMOGLOBIN HBA1C CAPILLARYS 2 FLEX PIERCING CAPILLARYS HBA1C CONTROLS CAPILLARYS HBA1C C by Sebia — Product Code LCP

K122101 is an FDA 510(k) premarket notification submitted by Sebia for the device "CAPILLARYS HEMOGLOBIN HBA1C CAPILLARYS 2 FLEX PIERCING CAPILLARYS HBA1C CONTROLS CAPILLARYS HBA1C C". The FDA issued a decision of Substantially Equivalent on December 6, 2012. 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.