FDA 510(k) K151321, D-100 HbA1c, D-100 HbA1c Calibrator Pack, by Bio-Rad Laboratories, Inc.

510(K) Number: K151321
Device Name: D-100 HbA1c, D-100 HbA1c Calibrator Pack
Manufacturer: Bio-Rad Laboratories, Inc.
Device Classification Name: hemoglobin a1c test system
Regulation Number: 862.1373
Classification Product Code: PDJ
Date Received: 05/18/2015
Decision Date: 12/09/2015
Regulation Medical Specialty: Clinical Chemistry