510(k) K973696

SYNCHRON SYSTEM HEMOGLOBIN ALC REAGENT by Beckman Instruments, Inc. — Product Code LCP

K973696 is an FDA 510(k) premarket notification submitted by Beckman Instruments, Inc. for the device "SYNCHRON SYSTEM HEMOGLOBIN ALC REAGENT". The FDA issued a decision of Substantially Equivalent on November 24, 1997. The device falls under product code LCP (Assay, Glycosylated Hemoglobin), a Class II device regulated under 21 CFR 864.7470. Beckman Instruments, Inc. has at least 10 other 510(k) clearances on record.