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510(k) K132618

ONETOUCH REVEAL by Lifescan, Inc. — Product Code MRZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 2013
Date Received
August 21, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Pump, Infusion
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

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  • K082513 — ONETOUCH VITA BLOOD GLUCOSE MONITORING SYSTEM (October 22, 2008)
  • K081318 — ONETOUCH ZOOM DIABETES MANAGEMENT PROGRAM (June 9, 2008)
  • K073231 — ONETOUCH ULTRALINK BLOOD GLUCOSE MONITORING SYSTEM (April 18, 2008)
  • K072543 — ONETOUCH SELECT BLOOD GLUCOSE MONITORING SYSTEM (October 5, 2007)
  • K062195 — MODIFICATION TO ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM (August 16, 2006)
  • K061118 — ONETOUCH ULTRAMINI BLOOD GLUCOSE MONITORING SYSTEM (May 19, 2006)
  • K053529 — ONETOUCH ULTRA 2 BLOOD GLUCOSE MONITORING SYSTEM (January 17, 2006)

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  • K171346 — Sapphire Sets (August 25, 2017)
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