FDA 510(k) Application Details - K222635

Device Classification Name	Abnormal Hemoglobin Quantitation   More FDA Info for this Device
510(K) Number	K222635
Device Name	Abnormal Hemoglobin Quantitation
Applicant	Trinity Biotech (Primus Corporation, dba Trinity Biotech) 4231 E. 75th Terrace Kansas City, MO 64132 US Other 510(k) Applications for this Company
Contact	Kaitlyn Eastman 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	08/31/2022
Decision Date	08/04/2023
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