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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
Recalls CDRH Recalls
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