FDA 510(k) Application Details - K221508

Device Classification Name	Whole Blood Hemoglobin Determination   More FDA Info for this Device
510(K) Number	K221508
Device Name	Whole Blood Hemoglobin Determination
Applicant	Sanguina, Inc. 147 Technology Parkway Ste 100 Peachtree Corners, GA 30092 US Other 510(k) Applications for this Company
Contact	Cathryn Cambria 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	05/24/2022
Decision Date	09/29/2023
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