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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
510(k) Number K124056
Device Name FREND PSA PLUS (REAGENT CARTRIDGE)
Applicant
Nanoentek, Inc.
1 Jack'S Hill Rd. Suite 1 (A&B)
Oxford,  CT  06478
Applicant Contact JUDITH E LOEBEL
Correspondent
Nanoentek, Inc.
1 Jack'S Hill Rd. Suite 1 (A&B)
Oxford,  CT  06478
Correspondent Contact JUDITH E LOEBEL
Regulation Number866.6010
Classification Product Code
LTJ  
Subsequent Product Code
KHO  
Date Received12/31/2012
Decision Date 05/29/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
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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