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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 K181017
Device Name Free Testosterone AccuBind ELISA Test System
Applicant
Monobind, Inc.
100 N. Pt.e Dr.
Lake Forest,  CA  92630
Applicant Contact Anthony Shatola
Correspondent
Monobind, Inc.
100 N. Pt.e Dr.
Lake Forest,  CA  92630
Correspondent Contact Anthony Shatola
Regulation Number862.1680
Classification Product Code
CDZ  
Date Received04/10/2018
Decision Date 07/20/2018
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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