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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 K021163
Device Name OCTEIA 25-HYDROXY VITAMIN D
Applicant
IMMUNODIAGNOSTIC SYSTEMS LTD.
10 DIDCOT WAY,
BOLDEN BUSINESS PARK
BOLDON, TYNE & WEAR,  GB NE35 9PD
Applicant Contact PAUL PUNTIN
Correspondent
UNDERWRITERS LABORATORIES, INC.
12 LABORATORY DR.
RESEARCH TRIANGLE,  NC  27709
Regulation Number862.1825
Classification Product Code
MRG  
Date Received04/11/2002
Decision Date 05/10/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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