510(k) K991850

SAFE AT-HOME TEST KIT FOR MONITORING HEMOGLOBIN ALC by Biosafe Laboratories, Inc. — Product Code LCP

K991850 is an FDA 510(k) premarket notification submitted by Biosafe Laboratories, Inc. for the device "SAFE AT-HOME TEST KIT FOR MONITORING HEMOGLOBIN ALC". The FDA issued a decision of Substantially Equivalent on November 26, 1999. The device falls under product code LCP (Assay, Glycosylated Hemoglobin), a Class II device regulated under 21 CFR 864.7470. Biosafe Laboratories, Inc. has at least 5 other 510(k) clearances on record.