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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 K032844
Device Name LIAISON 25 OH VITAMIN D
Applicant
DIASORIN, INC.
1951 NORTHWESTERN AVE.
P.O. BOX 285
STILLWATER,  MN  55082
Applicant Contact DAVID IKEDA
Correspondent
DIASORIN, INC.
1951 NORTHWESTERN AVE.
P.O. BOX 285
STILLWATER,  MN  55082
Correspondent Contact DAVID IKEDA
Regulation Number862.1825
Classification Product Code
MRG  
Subsequent Product Code
JJX  
Date Received09/11/2003
Decision Date 02/12/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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