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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Aldosterone
510(k) Number K142994
Device Name IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone Calibration Verifiers
Applicant
Immunodiagnostic Systems , Ltd.
10 Didcot Way,
Bolden Business Park
Boldon, Tyne & Wear,  GB NE35 9PD
Applicant Contact Mick Fenton
Correspondent
Immunodiagnostic Systems , Ltd.
10 Didcot Way,
Bolden Business Park
Boldon, Tyne & Wear,  GB NE35 9PD
Correspondent Contact Mick Fenton
Regulation Number862.1045
Classification Product Code
CJM  
Subsequent Product Code
JJX  
Date Received10/16/2014
Decision Date 04/21/2015
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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