FDA 510(k) Application Details - K232075

Device Classification Name	More FDA Info for this Device
510(K) Number	K232075
Device Name	StatStrip Glucose Hospital Meter System
Applicant	Nova Biomedical Corporation 200 Prospect St. Waltham, MA 02454 US Other 510(k) Applications for this Company
Contact	Abhinav Kulkarni 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	07/12/2023
Decision Date	02/23/2024
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