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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 K150052
Device Name TRUE METRIX AIR Self-Monitoring Blood Glucose System, TRUE METRIX AIR PRO Professional Blood Gulcose Monitoring System
Applicant
Nipro Diagnostics, Inc.
2400 NW 55th Court
Fort Lauderdale,  FL  33309
Applicant Contact Simeon Simone
Correspondent
Nipro Diagnostics, Inc.
2400 NW 55th Court
Fort Lauderdale,  FL  33309
Correspondent Contact Simeon Simone
Regulation Number862.1345
Classification Product Code
NBW  
Date Received01/12/2015
Decision Date 03/26/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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