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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Time, Prothrombin
510(k) Number K231711
Device Name microINR System
Applicant
Iline Microsystems, S.L.
Paseo Mikeletegi 69
San Sebastian-Donostia,  ES 20009
Applicant Contact Miren Itsaso Hormaeche
Correspondent
Iline Microsystems, S.L.
Paseo Mikeletegi 69
San Sebastian-Donostia,  ES 20009
Correspondent Contact Miren Itsaso Hormaeche
Regulation Number864.7750
Classification Product Code
GJS  
Date Received06/12/2023
Decision Date 07/11/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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