Cleared Traditional

microINR System

K180780 · Iline Microsystems, S.L. · Hematology
Jan 2019
Decision
305d
Days
Class 2
Risk

About This 510(k) Submission

K180780 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. (Donostia-San Sebastian, ES). The FDA issued a Cleared decision on January 25, 2019, 305 days after receiving the submission on March 26, 2018. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7750.

Submission Details

510(k) Number K180780 FDA.gov
FDA Decision Cleared SESE
Date Received March 26, 2018
Decision Date January 25, 2019
Days to Decision 305 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