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510(k) K120558

ONETOUCH REVEAL DIABETES MANAGEMENT APPLICATION by Lifescan, Inc. — Product Code NBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 2013
Date Received
February 24, 2012
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 Lifescan, Inc.

  • K132618 — ONETOUCH REVEAL (December 16, 2013)
  • K093745 — ONE TOUCH VERIO BLOOD GLUCOSE MONITORING SYSTEM (February 11, 2011)
  • K082590 — SYMPHONY METER REMOTE (December 17, 2008)
  • 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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