FDA 510(k) Application Details - K201217

Device Classification Name	System, Hemoglobin, Automated   More FDA Info for this Device
510(K) Number	K201217
Device Name	System, Hemoglobin, Automated
Applicant	HemoCue AB Kuvettgatan 1 Angelholm 26271 SE Other 510(k) Applications for this Company
Contact	Maria Fagerberg Other 510(k) Applications for this Contact
Regulation Number	864.5620   More FDA Info for this Regulation Number
Classification Product Code	GKR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/06/2020
Decision Date	08/04/2020
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