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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Thyroid-Stimulating Hormone
510(k) Number K131928
Device Name FREND TSH (REAGENT CARTRIDGE)
Applicant
Nanoentek USA, Inc.
1 Jacks' Hill Rd., Suite 1 (A&B)
Oxford,  CT  06478
Applicant Contact JUDITH E LOEBEL
Correspondent
Nanoentek USA, Inc.
1 Jacks' Hill Rd., Suite 1 (A&B)
Oxford,  CT  06478
Correspondent Contact JUDITH E LOEBEL
Regulation Number862.1690
Classification Product Code
JLW  
Date Received06/27/2013
Decision Date 03/14/2014
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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