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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 K132121
Device Name STATSTRIP GLUCOSE HOSPITAL METER SYSTEM
Applicant
Nova Biomedical Corporation
200 Prospect St.
Walham,  MA  02454
Applicant Contact PAUL W MACDONALD, PHD
Correspondent
Nova Biomedical Corporation
200 Prospect St.
Walham,  MA  02454
Correspondent Contact PAUL W MACDONALD, PHD
Regulation Number862.1345
Classification Product Code
PZI  
Date Received07/10/2013
Decision Date 09/24/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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