FDA 510(k) Application Details - K182549

Device Classification Name	More FDA Info for this Device
510(K) Number	K182549
Device Name	StatStrip Xpress 2 Glucose Hospital Meter System
Applicant	Nova Biomedical Corporation 200 Prospect Street Waltham, MA 02454 US Other 510(k) Applications for this Company
Contact	Khushboo Surendran 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	09/17/2018
Decision Date	12/13/2018
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