FDA 510(k) Application Details - K192842

Device Classification Name	Control, Hemoglobin   More FDA Info for this Device
510(K) Number	K192842
Device Name	Control, Hemoglobin
Applicant	Eurotrol B.V. Keplerlaan 20 EDE 6716BS NL Other 510(k) Applications for this Company
Contact	Elisanne Biemans 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	10/03/2019
Decision Date	11/15/2019
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