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510(k) K243543

microINR System by Iline Microsystems, S.L. — Product Code GJS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 2025
Date Received
November 15, 2024
Clearance Type
Traditional
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 Iline Microsystems, S.L.

  • K251564 — microINR System (July 21, 2025)
  • K231711 — microINR System (July 11, 2023)
  • K201185 — microINR System (December 18, 2020)
  • K180780 — microINR System (January 25, 2019)

Other clearances for product code GJS

  • K253188 — CoaguChek XS Plus System (October 24, 2025)
  • K251564 — microINR System (July 21, 2025)
  • 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)
  • K183255 — Coag-Sense Prothrombin Time (PT) / INR Monitoring Device (February 21, 2019)