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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK130181
Test Name Entra Health, Oh' Care Professional Blood Glucose Monitoring System  
Manufacturer NameInfopia Co, Ltd.
Consumer Information Phone Number1(877)458-2646
Test TypeGlucose monitoring devices (prescription use only)
Effective Date05/30/2017
Device Classification Name System, Test, Blood Glucose, Over The Counter
510(k) Number K130181
Device Name GLUNEO BLOOD GLUCOSE MONITORING SYSTEM, AND PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM
Applicant
Infopia Co, Ltd.
1515 E. Katella Ave.
Unit 2115
Anaheim,  CA  92805
Applicant Contact Priscilla Chung
Correspondent
Infopia Co, Ltd.
1515 E. Katella Ave.
Unit 2115
Anaheim,  CA  92805
Correspondent Contact Priscilla Chung
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
JJX   JQP   LFR  
Date Received01/25/2013
Decision Date 07/31/2013
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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