FDA 510(k) Application Details - K210933

Device Classification Name	Glucose Oxidase, Glucose   More FDA Info for this Device
510(K) Number	K210933
Device Name	Glucose Oxidase, Glucose
Applicant	YSI Inc. 1725 Brannum Ln Yellow Springs, OH 45387 US Other 510(k) Applications for this Company
Contact	Eric Lute 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	03/29/2021
Decision Date	09/30/2024
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