Cleared Traditional

microINR System

K201185 · Iline Microsystems, S.L. · Hematology
Dec 2020
Decision
231d
Days
Class 2
Risk

About This 510(k) Submission

K201185 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 December 18, 2020, 231 days after receiving the submission on May 1, 2020. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7750.

Submission Details

510(k) Number K201185 FDA.gov
FDA Decision Cleared SESE
Date Received May 01, 2020
Decision Date December 18, 2020
Days to Decision 231 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