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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 K201185
Device Name microINR System
Applicant
Iline Microsystems, S.L.
Paseo Mikeletegi 69
San Sebastian-Donostia,  ES 20009
Applicant Contact Miren Itaso Hormaeche
Correspondent
Zivd, LLC
62 Pollard Rd.
Plaistow,  NH  03865
Correspondent Contact Marcia L Zucker
Regulation Number864.7750
Classification Product Code
GJS  
Date Received05/01/2020
Decision Date 12/18/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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