Cleared Traditional

microINR System

K243543 · Iline Microsystems, S.L. · Hematology
Feb 2025
Decision
104d
Days
Class 2
Risk

About This 510(k) Submission

K243543 is an FDA 510(k) clearance for the microINR System, a Test, Time, Prothrombin (Class II — Special Controls, product code GJS), submitted by Iline Microsystems, S.L. (San Sebastian-Donostia, ES). The FDA issued a Cleared decision on February 27, 2025, 104 days after receiving the submission on November 15, 2024. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7750.

Submission Details

510(k) Number K243543 FDA.gov
FDA Decision Cleared SESE
Date Received November 15, 2024
Decision Date February 27, 2025
Days to Decision 104 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GJS — Test, Time, Prothrombin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7750