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510(k) K102383

MICRODOT & MICRODOT XTRA by Cambridge Sensors Limited — Product Code NBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 2012
Date Received
August 23, 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

Other clearances by Cambridge Sensors Limited

  • K083273 — MICRODOT XTRA (November 19, 2009)
  • K070524 — MICRODOT BLOOD GLUCOSE MONITORING SYSTEM (June 22, 2007)

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