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FDA 510(k)

microINR System

K-Number: K251564 · 2025-07-21

ApplicantIline Microsystems, S.L.
Decision Date2025-07-21
Product CodeGJS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

microINR System is a medical device manufactured by Iline Microsystems, S.L.. It received FDA 510(k) clearance on 2025-07-21 under approval number K251564. The device is classified under product code GJS. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the microINR System?

microINR System is a medical device that received FDA 510(k) clearance on 2025-07-21. It is manufactured by Iline Microsystems, S.L.. The 510(k) number is K251564.

When was microINR System approved by the FDA?

microINR System received FDA 510(k) clearance on 2025-07-21, under approval number K251564.

What company makes microINR System?

microINR System is manufactured by Iline Microsystems, S.L..

What is the FDA product code for microINR System?

The FDA product code for microINR System is GJS.

Other Devices by Iline Microsystems, S.L.

K180780microINR System K201185microINR System K231711microINR System K243543microINR System

Related Devices (Code: GJS)

K151964Xprecia Stride Coagulation System, Xprecia System PT ControlsSiemens Healthcare Diagnostics K170960CoaguChek Vantus SystemRoche Diagnostics K180684CoaguChek XS Plus SystemRoche Diagnostics K180693CoaguChek XS Pro SystemRoche Diagnostics K183255Coag-Sense Prothrombin Time (PT) / INR Monitoring DeviceCoagusense, Inc. K180780microINR SystemIline Microsystems, S.L.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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