510(k) K991246

FRUCTOSAMINE, MODEL FR 106-01 by A.P. Total Care, Inc. — Product Code LCP

K991246 is an FDA 510(k) premarket notification submitted by A.P. Total Care, Inc. for the device "FRUCTOSAMINE, MODEL FR 106-01". The FDA issued a decision of Substantially Equivalent on December 16, 1999. The device falls under product code LCP (Assay, Glycosylated Hemoglobin), a Class II device regulated under 21 CFR 864.7470. A.P. Total Care, Inc. has at least 10 other 510(k) clearances on record.