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510(k) K022922

HARMONY INR MONITORING SYSTEM by Lifescan, Inc. — Product Code GJS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 2002
Date Received
September 4, 2002
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Time, Prothrombin
Device Class
Class II
Regulation Number
864.7750
Review Panel
HE
Submission Type

Other clearances by Lifescan, Inc.

  • K132618 — ONETOUCH REVEAL (December 16, 2013)
  • K120558 — ONETOUCH REVEAL DIABETES MANAGEMENT APPLICATION (February 7, 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)

Other clearances for product code GJS

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  • K251564 — microINR System (July 21, 2025)
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  • K230802 — Xprecia Prime Coagulation System (March 15, 2024)
  • K220282 — i-STAT PTplus Cartridge with the i-STAT 1 System (July 14, 2023)
  • K231711 — microINR System (July 11, 2023)
  • K211485 — STA- NeoPTimal (December 23, 2022)
  • K212779 — Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing (October 5, 2022)
  • K213426 — HemosIL ReadiPlasTin (August 16, 2022)
  • K201185 — microINR System (December 18, 2020)