Cleared Special

microINR System

K231711 · Iline Microsystems, S.L. · Hematology
Jul 2023
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K231711 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 July 11, 2023, 29 days after receiving the submission on June 12, 2023. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7750.

Submission Details

510(k) Number K231711 FDA.gov
FDA Decision Cleared SESE
Date Received June 12, 2023
Decision Date July 11, 2023
Days to Decision 29 days
Submission Type Special
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