FDA 510(k) Application Details - K163215

Device Classification Name	Whole Blood Hemoglobin Determination   More FDA Info for this Device
510(K) Number	K163215
Device Name	Whole Blood Hemoglobin Determination
Applicant	SANGUINA, LLC 575 14TH STREET ATLANTA, GA 30318 US Other 510(k) Applications for this Company
Contact	ERIKA TYBURSKI Other 510(k) Applications for this Contact
Regulation Number	864.7500   More FDA Info for this Regulation Number
Classification Product Code	KHG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/16/2016
Decision Date	09/13/2017
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