MicroINR System

Test, Time, Prothrombin

ILine Microsystems S.L.

The following data is part of a premarket notification filed by Iline Microsystems S.l. with the FDA for Microinr System.

Pre-market Notification Details

Device IDK201185
510k NumberK201185
Device Name:MicroINR System
ClassificationTest, Time, Prothrombin
Applicant iLine Microsystems S.L. Paseo Mikeletegi, 69 San Sebastian-donostia,  ES 20009
ContactMiren Itaso Hormaeche
CorrespondentMarcia L Zucker
ZIVD LLC 62 Pollard Rd Plaistow,  NH  03865
Product CodeGJS  
CFR Regulation Number864.7750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-01
Decision Date2020-12-18

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