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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name radioimmunoassay, free thyroxine
510(k) Number K152422
Device Name FREND™ Free T4 Test System
Applicant
NANOENTEK USA INC
5627 STONERIDGE DRIVE SUITE 304
PLEASANTON,  CA  94588
Applicant Contact JIMMY CHEN
Correspondent
NEW WORLD REGULATORY SOLUTIONS, INC.
1983 HAZELWOOD ROAD
TOMS RIVER,  NJ  08753
Correspondent Contact MAUREEN GARNER
Regulation Number862.1695
Classification Product Code
CEC  
Date Received08/26/2015
Decision Date 02/17/2016
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
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