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510(k) K023279

GLUCOLEADER VALUE by Hmd Biomedical, Inc. — Product Code NBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 2003
Date Received
October 1, 2002
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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  • K072369 — EVOLUTION BLOOD GLUCOSE MONITORING SYSTEM (March 21, 2008)
  • K032985 — GLUCOLEADER ENHANCE SELF-MONITORING OF BLOOD GLUCOSE SYSTEM (October 21, 2003)

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