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510(k) K131173

FIA Blood Glucose Monitoring System (G2) by Hmd Biomedical, Inc. — Product Code NBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 2014
Date Received
April 25, 2013
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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  • K113314 — PRECICHEK NS-101 POCT PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM (November 9, 2012)
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  • K113307 — GL GOODLIFE SERIES BLOOD GLUCOSE MONITORING SYSMTEM (July 27, 2012)
  • K072369 — EVOLUTION BLOOD GLUCOSE MONITORING SYSTEM (March 21, 2008)
  • K032985 — GLUCOLEADER ENHANCE SELF-MONITORING OF BLOOD GLUCOSE SYSTEM (October 21, 2003)
  • K023279 — GLUCOLEADER VALUE (August 4, 2003)

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