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FDA 510(k)

microINR System

K-Number: K201185 · 2020-12-18

ApplicantIline Microsystems, S.L.
Decision Date2020-12-18
Product CodeGJS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

microINR System is the device name listed in this FDA 510(k) record. The listed applicant is Iline Microsystems, S.L.. It received FDA 510(k) clearance on 2020-12-18 under 510(k) number K201185. 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 2020-12-18. The listed applicant is Iline Microsystems, S.L.. The 510(k) number is K201185.

When did microINR System receive FDA 510(k) clearance?

microINR System received FDA 510(k) clearance on 2020-12-18, under 510(k) number K201185.

Who is the listed applicant for microINR System?

The FDA 510(k) record lists Iline Microsystems, S.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for microINR System?

The FDA product code for microINR System is GJS.

Other records listing Iline Microsystems, S.L. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251564microINR SystemK243543microINR SystemK231711microINR SystemK180780microINR System

Related Devices (Code: GJS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253188CoaguChek XS Plus SystemRoche DiagnosticsK251564microINR SystemIline Microsystems, S.L.K243543microINR SystemIline Microsystems, S.L.K230802Xprecia Prime Coagulation SystemUniversal Biosensors Pty, Ltd.K220282i-STAT PTplus Cartridge with the i-STAT 1 SystemAbbott LaboratoriesK231711microINR 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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