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510(k) K152365

AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System by Agamatrix, Inc. — Product Code NBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 2016
Date Received
August 21, 2015
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 Agamatrix, Inc.

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  • K130535 — IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION (April 17, 2013)
  • K103544 — IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION, R (December 7, 2011)
  • K101597 — WAVESENSE DIABETES MANAGER MODEL VERSION 1.3.4 (October 18, 2010)
  • K083265 — JAZZ WIRELESS BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-03381 (February 3, 2009)
  • 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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