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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 K181043
Device Name StatStrip Glucose Hospital Meter System
Applicant
Nova Biomedical Corporation
200 Prospect Street
waltham,  MA  02454
Applicant Contact john mchale
Correspondent
Nova Biomedical Corporation
200 Prospect Street
waltham,  MA  02454
Correspondent Contact john mchale
Regulation Number862.1345
Classification Product Code
PZI  
Date Received04/19/2018
Decision Date 07/12/2018
Decision substantially equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
summary summary
FDA Review Decision Summary
CLIA Waiver CLIA Waiver Decision Summary
Type Dual Track
Reviewed by Third Party No
Combination Product No
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