510(k) K140801

VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM/TESTING SYSTEM by Bio-Rad Laboratories, Inc. — Product Code LCP

K140801 is an FDA 510(k) premarket notification submitted by Bio-Rad Laboratories, Inc. for the device "VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM/TESTING SYSTEM". The FDA issued a decision of Substantially Equivalent on June 25, 2014. The device falls under product code LCP (Assay, Glycosylated Hemoglobin), a Class II device regulated under 21 CFR 864.7470. Bio-Rad Laboratories, Inc. has at least 10 other 510(k) clearances on record.