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510(k) K103544

IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION, REV D by Agamatrix, Inc. — Product Code NBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 7, 2011
Date Received
December 2, 2010
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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  • K101597 — WAVESENSE DIABETES MANAGER MODEL VERSION 1.3.4 (October 18, 2010)
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  • K073573 — WAVESENSE KEYNOTE CODELESS BLOOD GLUCOSE MONITORING SYSTEM (January 30, 2008)
  • K072413 — MODIFICATION TO: JAZZ BLOOD GLUCOSE MONITORING SYSTEM (September 27, 2007)
  • K071393 — JAZZ BLOOD GLUCOSE MONITORING SYSTEM (July 20, 2007)

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