FDA 510(k) Application Details - K221326

Device Classification Name	Assay, Glycosylated Hemoglobin   More FDA Info for this Device
510(K) Number	K221326
Device Name	Assay, Glycosylated Hemoglobin
Applicant	Nova Biomedical Corporation 200 Prospect St. Waltham, MA 02454 US Other 510(k) Applications for this Company
Contact	Cesidio Tempesta Other 510(k) Applications for this Contact
Regulation Number	864.7470   More FDA Info for this Regulation Number
Classification Product Code	LCP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/06/2022
Decision Date	11/22/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Dual Track
Reviewed By Third Party	N
Expedited Review