510(k) K052101

C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1C by Roche Diagnostics — Product Code KRZ

K052101 is an FDA 510(k) premarket notification submitted by Roche Diagnostics for the device "C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1C". The FDA issued a decision of Substantially Equivalent on August 26, 2005. The device falls under product code KRZ (Calibrator For Hemoglobin And Hematocrit Measurement), a Class II device regulated under 21 CFR 864.8165. Roche Diagnostics has at least 10 other 510(k) clearances on record.