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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
510(k) Number K200475
Device Name IDS-iSYS Ostase BAP
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 Number862.1050
Classification Product Code
CIN  
Date Received02/26/2020
Decision Date 09/30/2020
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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