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510(k) K180780

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 25, 2019
Date Received
March 26, 2018
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)
  • K243543 — microINR System (February 27, 2025)
  • K231711 — microINR System (July 11, 2023)
  • K201185 — microINR System (December 18, 2020)

Other clearances for product code GJS

  • K253188 — CoaguChek XS Plus System (October 24, 2025)
  • K251564 — microINR System (July 21, 2025)
  • K243543 — microINR System (February 27, 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)