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510(k) K132821

AGAMATRIX HEALTH MANAGER by Agamatrix, Inc. — Product Code NBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 2013
Date Received
September 9, 2013
Clearance Type
Special
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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  • K072413 — MODIFICATION TO: JAZZ BLOOD GLUCOSE MONITORING SYSTEM (September 27, 2007)
  • K071393 — JAZZ BLOOD GLUCOSE MONITORING SYSTEM (July 20, 2007)

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