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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prescription Use Blood Glucose Meter For Near-Patient Testing
510(k) Number K232075
Device Name StatStrip Glucose Hospital Meter System
Applicant
Nova Biomedical Corporation
200 Prospect St.
Waltham,  MA  02454
Applicant Contact Abhinav Kulkarni
Correspondent
Nova Biomedical Corporation
200 Prospect St.
Waltham,  MA  02454
Correspondent Contact Abhinav Kulkarni
Regulation Number862.1345
Classification Product Code
PZI  
Date Received07/12/2023
Decision Date 02/23/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Dual Track
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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