microINR System— 510(k) K243543

Name: FDA 510(k) clearance K243543
Creator: U.S. Food and Drug Administration
Published: 2025-02-27

Substantially Equivalent

Iline Microsystems, S.L.

FDA 510(k) clearance K243543 for microINR System, Substantially Equivalent on 2025-02-27. Applicant: Iline Microsystems, S.L.. Device class: 2.

Clearance details

Applicant: Iline Microsystems, S.L.
Product code: Code GJS
Device class: Class 2
Regulation: 21 CFR 864.7750
Advisory panel: Hematology
Date received: 2024-11-15
Decision date: 2025-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Sebastian-Donostia, ES

Download summary PDF View on FDA.gov ↗

Recent devices under product code GJS

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K253188 — CoaguChek XS Plus System2025-10-24
K251564 — microINR System2025-07-21
K230802 — Xprecia Prime Coagulation System2024-03-15
K220282 — i-STAT PTplus Cartridge with the i-STAT 1 System2023-07-14
K231711 — microINR System2023-07-11

More clearances from Iline Microsystems, S.L.

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K201185 — microINR System2020-12-18
K180780 — microINR System2019-01-25

Adverse events under product code GJS

product code GJS

Death: 4
Injury: 229
Malfunction: 4,852
Total: 5,085

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.