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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 K051110
Device Name 1,25-DIHYDROXY VITAMIN D EIA
Applicant
Immunodiagnostic Systems , Ltd.
10 Didcot Way,
Bolden Business Park
Boldon, Tyne & Wear,  GB NE35 9PD
Applicant Contact PAUL PUNTIN
Correspondent
Immunodiagnostic Systems , Ltd.
10 Didcot Way,
Bolden Business Park
Boldon, Tyne & Wear,  GB NE35 9PD
Correspondent Contact PAUL PUNTIN
Regulation Number862.1825
Classification Product Code
MRG  
Date Received05/02/2005
Decision Date 07/06/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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