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FDA 510(k) K050574, AFINION HBALC, by Axis-Shield Poc AS

FDA 510(k) K050574, AFINION HBALC, by Axis-Shield Poc AS

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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
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