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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 K190121
Device Name IDS SHBG
Applicant
Immunodiagnostic Systems Ltd.
10 Didcot Way Boldon Business Park
Boldon,  GB NE35 9PD
Applicant Contact Mick Henderson
Correspondent
Immunodiagnostic Systems Ltd.
10 Didcot Way Boldon Business Park
Boldon,  GB NE35 9PD
Correspondent Contact Mick Henderson
Regulation Number862.1680
Classification Product Code
CDZ  
Date Received01/25/2019
Decision Date 06/17/2019
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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