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510(k) K093819

ARKRAY DIABETES DATA MANAGEMENT SOFTWARE (SMBG VIEWER) by Arkray Factory USA, Inc. — Product Code NBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 2010
Date Received
December 14, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Blood Glucose, Over The Counter
Device Class
Class II
Regulation Number
862.1345
Review Panel
CH
Submission Type

Other clearances by Arkray Factory USA, Inc.

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  • K090653 — POCKETCHEM EZ BLOOD GLUCOSE MONITORING SYSTEM (October 9, 2009)
  • K090332 — ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 46001 (August 14, 2009)
  • K082417 — GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, MODEL 73110 (October 21, 2008)
  • K073416 — ARKRAY GLUCOCARD 01 BLOOD MONITORING SYSTEM (June 13, 2008)
  • K063771 — GLUCOCARD X-METER BLOOD GLUCOSE MONITORING SYSTEM (August 9, 2007)

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