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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Testosterones And Dihydrotestosterone
510(k) Number K153577
Device Name FREND Testosterone Test System
Applicant
Nanoentek USA, Inc.
5627 Stoneridge Dr. Suite 304
Pleasanton,  CA  94588
Applicant Contact Jimmy Chen
Correspondent
Newworld Regulatory Solutions, Inc.
1983 Hazelwood Rd.
Oms River,  NJ  08753
Correspondent Contact Maureen N Garner
Regulation Number862.1680
Classification Product Code
CDZ  
Date Received12/15/2015
Decision Date 10/14/2016
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
Predetermined Change
Control Plan Authorized		 No
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