510(k) K071132

G8 AUTOMATED HPLC ANALYZER, MODEL HLC-723 G8 by Tosoh Bioscience, Inc. — Product Code LCP

K071132 is an FDA 510(k) premarket notification submitted by Tosoh Bioscience, Inc. for the device "G8 AUTOMATED HPLC ANALYZER, MODEL HLC-723 G8". The FDA issued a decision of Substantially Equivalent on September 16, 2008. The device falls under product code LCP (Assay, Glycosylated Hemoglobin), a Class II device regulated under 21 CFR 864.7470. Tosoh Bioscience, Inc. has at least 10 other 510(k) clearances on record.