510(k) K875354

UNISTEP CAPILLARY BLOOD COLLECTION SYSTEM by Ulster Scientific, Inc. — Product Code LCP

K875354 is an FDA 510(k) premarket notification submitted by Ulster Scientific, Inc. for the device "UNISTEP CAPILLARY BLOOD COLLECTION SYSTEM". The FDA issued a decision of Substantially Equivalent on Feb 17, 1988. The device falls under product code LCP (Assay, Glycosylated Hemoglobin), a Class II device regulated under 21 CFR 864.7470. Ulster Scientific, Inc. has at least 10 other 510(k) clearances on record.