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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 K112725
Device Name LIAISON 25 OH VITAMIN D TOTAL ASSAY
Applicant
DIASORIN, INC.
p.o. box 103
baldwin,  MD  21013
Contact judi smith
Regulation Number862.1825
Classification Product Code
MRG  
Date Received09/20/2011
Decision Date 01/20/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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