FDA 510(k) Application Details - K180762

Device Classification Name	Abnormal Hemoglobin Quantitation   More FDA Info for this Device
510(K) Number	K180762
Device Name	Abnormal Hemoglobin Quantitation
Applicant	SEBIA 1705 Corporate Drive, Suite 400 Norcross, GA 30093 US Other 510(k) Applications for this Company
Contact	Karen Anderson Other 510(k) Applications for this Contact
Regulation Number	864.7415   More FDA Info for this Regulation Number
Classification Product Code	GKA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/23/2018
Decision Date	12/14/2018
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