FDA.report

510(k) K243543

Device
microINR System
Applicant
Iline Microsystems, S.L.
510(k) number
K243543
Product code
GJS
Decision
Substantially Equivalent (SESE)
Decision date
2025-02-27
Date received
2024-11-15
Regulation
864.7750
Classification name
Test, Time, Prothrombin
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Miren Itsaso Hormaeche
Address
Paseo Mikeletegi 69 San Sebastian-Donostia ES 20009 20009

FDA Registration Numbers

Source Documents

510(k) summary PDF

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K180693CoaguChek XS Pro SystemRoche Diagnostics2018-04-19
K180684CoaguChek XS Plus SystemRoche Diagnostics2018-04-19
K170960CoaguChek Vantus SystemRoche Diagnostics2017-12-25
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