FDA 510(k) Application Details - K152986

Device Classification Name	More FDA Info for this Device
510(K) Number	K152986
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	PAUL W. MACDONALD 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	10/09/2015
Decision Date	01/27/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review