FDA 510(k) Application Details - K203549

Device Classification Name	Glucose Oxidase, Glucose   More FDA Info for this Device
510(K) Number	K203549
Device Name	Glucose Oxidase, Glucose
Applicant	Nova Biomedical Corporation 200 Prospect Street Waltham, ME 02454 US Other 510(k) Applications for this Company
Contact	Rachel Gilbert Other 510(k) Applications for this Contact
Regulation Number	862.1345   More FDA Info for this Regulation Number
Classification Product Code	CGA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/04/2020
Decision Date	10/18/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review