HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High

Control, Hemoglobin

Eurotrol B.V.

The following data is part of a premarket notification filed by Eurotrol B.v. with the FDA for Hemotrol Duo Low, Hemotrol Duo Normal, Hemotrol Duo High.

Pre-market Notification Details

Device IDK192842
501k NumberK192842
Device Name:HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High
ClassificationControl, Hemoglobin
Applicant Eurotrol B.V. Keplerlaan 20 Ede,  NL 6716bs
ContactElisanne Biemans
CorrespondentElisanne Biemans
Eurotrol B.V. Keplerlaan 20 Ede,  NL 6716bs
Product CodeGGM  
CFR Regulation Number864.8625 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyHematology
501k Review PanelHematology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-03
Decision Date2019-11-15

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