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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 K123253
Device Name IDS ISYS 1,25 DIHYDROXY VITAMIN D, IDS-ISYS, 1,25 DIHYDROXY VITAMIN D CONTROL SET, AND IDS ISYS 1,25 DIHYDROXY VITAMIN D
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 Number862.1825
Classification Product Code
MRG  
Subsequent Product Code
JJX  
Date Received10/17/2012
Decision Date 06/18/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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