510(k) K070819

VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM, AND VARIANT II TURBO LINK HEMOGLOBIN TESTING WITH MODEL, 270-2716, by Bio-Rad Laboratories Inc., Clinical Systems Divisi — Product Code LCP

K070819 is an FDA 510(k) premarket notification submitted by Bio-Rad Laboratories Inc., Clinical Systems Divisi for the device "VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM, AND VARIANT II TURBO LINK HEMOGLOBIN TESTING WITH MODEL, 270-2716,". The FDA issued a decision of Substantially Equivalent on June 25, 2007. The device falls under product code LCP (Assay, Glycosylated Hemoglobin), a Class II device regulated under 21 CFR 864.7470. Bio-Rad Laboratories Inc., Clinical Systems Divisi has at least 2 other 510(k) clearances on record.