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U.S. Department of Health and Human Services

OTC - Over The Counter

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Document NumberK160156
Test Name Nova Biomedical Corp., StatStrip Xpress Blood Glucose Monitoring System  
Manufacturer NameNOVA BIOMEDICAL CORPORATION
Consumer Information Phone Number1(800)681-7390
Test TypeGlucose
Effective Date06/29/2016
Device Classification Name system, test, blood glucose, over the counter
510(k) Number K160156
Device Name StatStrip Xpress Blood Glucose Monitoring System
Applicant
NOVA BIOMEDICAL CORPORATION
200 PROSPECT STREET
WALTHAM,  MA  02454
Applicant Contact Eliza Wang
Correspondent
NOVA BIOMEDICAL CORPORATION
200 PROSPECT STREET
WALTHAM,  MA  02454
Correspondent Contact Eliza Wang
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
CGA   JJX  
Date Received01/22/2016
Decision Date 06/23/2016
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
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