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510(k) K090332

ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 46001 by Arkray Factory USA, Inc. — Product Code NBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 2009
Date Received
February 10, 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

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  • K090653 — POCKETCHEM EZ BLOOD GLUCOSE MONITORING SYSTEM (October 9, 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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