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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK090405
Test Name Infopia USA LipidPro lipid profile and glucose measuring system  
Manufacturer NameInfopia Co, Ltd.
Consumer Information Phone Number1(888)446-3246
Test TypeGlucose monitoring devices (FDA cleared/home use)
Effective Date12/02/2009
Device Classification Name System, Test, Blood Glucose, Over The Counter
510(k) Number K090405
Device Name LIPIDPRO SYSTEM
Applicant
Infopia Co, Ltd.
13340 E Firestone Blvd.
Suite J
Santa Fe Springs,  CA  90670
Applicant Contact PRISCILLA JUHEE CHUNG
Correspondent
Infopia Co, Ltd.
13340 E Firestone Blvd.
Suite J
Santa Fe Springs,  CA  90670
Correspondent Contact PRISCILLA JUHEE CHUNG
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
CGA   CHH   JGY   JJX   LBR  
Date Received02/19/2009
Decision Date 12/01/2009
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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