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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 K140100
Device Name TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRIX PRO PROFESSIONAL MONITORING BLOOD GLUCOSE SYSTEM
Applicant
Nipro Diagnostics, Inc.
2400 NW 55th Court
Fort Lauderdale,  FL  33309
Applicant Contact BETH FOSTER
Correspondent
Nipro Diagnostics, Inc.
2400 NW 55th Court
Fort Lauderdale,  FL  33309
Correspondent Contact BETH FOSTER
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
LFR  
Date Received01/15/2014
Decision Date 08/01/2014
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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