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510(k) K072409

AFINION ACR AND ACR CONTROL by Axis-Shield Poc AS — Product Code JFY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 2008
Date Received
August 27, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzymatic Method, Creatinine
Device Class
Class II
Regulation Number
862.1225
Review Panel
CH
Submission Type

Other clearances by Axis-Shield Poc AS

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