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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK130295
Test Name Jant Pharmacal Corp, LipidPlus Professional Lipid Profile and Glucose Measuring System  
Manufacturer NameInfopia Co, Ltd.
Consumer Information Phone Number1(800)676-5565
Test TypeGlucose monitoring devices (prescription use only)
Effective Date11/12/2013
Device Classification Name System, Test, Blood Glucose, Over The Counter
510(k) Number K130295
Device Name LIPIDPRO LIPID PROFILE AND GLUCOSE MEASURING SYSTEM, LIPIDPRO PROFESSIONAL LIPID PROFILE AND GLUCOSE MEASURING SYSTEM.
Applicant
Infopia Co, Ltd.
2341 W Crescent Ave. #3
Anaheim,  CA  92801
Applicant Contact Priscilla Chung
Correspondent
Infopia Co, Ltd.
2341 W Crescent Ave. #3
Anaheim,  CA  92801
Correspondent Contact Priscilla Chung
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
CGA   CHH   JGY   JJX   LBR  
Date Received02/06/2013
Decision Date 06/21/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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