FDA 510(k) Application Details - K192931

Device Classification Name	Abnormal Hemoglobin Quantitation   More FDA Info for this Device
510(K) Number	K192931
Device Name	Abnormal Hemoglobin Quantitation
Applicant	Helena Laboratories, Corp. 1530 Lingbergh Drive Beaumont, TX 77707 US Other 510(k) Applications for this Company
Contact	Justin Padia 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	10/17/2019
Decision Date	04/19/2022
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