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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
Applicant Contact Judi Smith
Correspondent
DIASORIN, INC.
P.O. BOX 103
BALDWIN,  MD  21013
Correspondent Contact Judi Smith
Regulation Number862.1825
Classification Product Code
MRG  
Date Received09/20/2011
Decision Date 01/20/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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