FDA 510(k) Application Details - K193407

Device Classification Name	System, Test, Blood Glucose, Over The Counter   More FDA Info for this Device
510(K) Number	K193407
Device Name	System, Test, Blood Glucose, Over The Counter
Applicant	Ascensia Diabetes Care 100 Summit Lake Drive Valhalla, NY 10595 US Other 510(k) Applications for this Company
Contact	Colleen Burdel Other 510(k) Applications for this Contact
Regulation Number	862.1345   More FDA Info for this Regulation Number
Classification Product Code	NBW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/09/2019
Decision Date	12/23/2021
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