FDA 510(k) Application Details - K182744

Device Classification Name	Control, Hemoglobin   More FDA Info for this Device
510(K) Number	K182744
Device Name	Control, Hemoglobin
Applicant	EUROTROL B.V. Keplerlaan 20 Ede 6716BS NL Other 510(k) Applications for this Company
Contact	Mylene de Boer Other 510(k) Applications for this Contact
Regulation Number	864.8625   More FDA Info for this Regulation Number
Classification Product Code	GGM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/28/2018
Decision Date	02/01/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review