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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Blood Glucose, Over The Counter
510(k) Number K143548
Device Name TRUE METRIX GO Self Monitoring Blood Glucose System
Applicant
Trividia Health, Inc.
2400 NW 55th Ct.
Fort Lauderdale,  FL  33309
Applicant Contact Beth Foster
Correspondent
Trividia Health, Inc.
2400 NW 55th Ct.
Fort Lauderdale,  FL  33309
Correspondent Contact Roberto Cunha
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
LFR  
Date Received12/15/2014
Decision Date 04/01/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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