FDA 510(k) Application Details - K181043

Device Classification Name	More FDA Info for this Device
510(K) Number	K181043
Device Name	StatStrip Glucose Hospital Meter System
Applicant	Nova Biomedical Corporation 200 Prospect Street Waltham, MA 02454 US Other 510(k) Applications for this Company
Contact	John Mchale Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PZI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/19/2018
Decision Date	07/12/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Dual Track
Reviewed By Third Party	N
Expedited Review