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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Vitamin D
510(k) Number K140554
Device Name IDS-ISYS 25-HYDROXY VITAMIN DS, AND IDS-ISYS 25 HYDROXY VITAMIN DS CONTROL SET
Applicant
Immunodiagnostic Systems , Ltd.
10 Didcot Way,
Bolden Business Park
Boldon, Tyne & Wear,  GB NE35 9PD
Applicant Contact MICK HENDERSON
Correspondent
Immunodiagnostic Systems , Ltd.
10 Didcot Way
Boldon Business Park
Tyne & Wear,  GB NE35 9PD
Correspondent Contact MICK HENDERSON
Regulation Number862.1825
Classification Product Code
MRG  
Subsequent Product Code
JJX  
Date Received03/04/2014
Decision Date 12/19/2014
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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