510(k) K864643

GLYCOSCREEN GLYCOSYLATED HEMOGLOBIN ASSAY KIT by Pacific Hemostasis — Product Code LCP

K864643 is an FDA 510(k) premarket notification submitted by Pacific Hemostasis for the device "GLYCOSCREEN GLYCOSYLATED HEMOGLOBIN ASSAY KIT". The FDA issued a decision of Substantially Equivalent on April 28, 1987. The device falls under product code LCP (Assay, Glycosylated Hemoglobin), a Class II device regulated under 21 CFR 864.7470. Pacific Hemostasis has at least 10 other 510(k) clearances on record.