FDA 510(k), K050574, AFINION HBALC

510(K) Number: K050574
Device Name: AFINION HBALC
Manufacturer: AXIS-SHIELD POC AS
Device Classification Name: assay, glycosylated hemoglobin
Regulation Number: 864.7470
Classification Product Code: LCP
Date Received: 03/07/2005
Decision Date: 07/22/2005
Regulation Medical Specialty: Hematology