LIAISON 25 OH VITAMIN D TOTAL ASSAY

System, Test, Vitamin D

DIASORIN, INC.

The following data is part of a premarket notification filed by Diasorin, Inc. with the FDA for Liaison 25 Oh Vitamin D Total Assay.

Pre-market Notification Details

Device IDK112725
510k NumberK112725
Device Name:LIAISON 25 OH VITAMIN D TOTAL ASSAY
ClassificationSystem, Test, Vitamin D
Applicant DIASORIN, INC. P.O. BOX 103 Baldwin,  MD  21013
ContactJudi Smith
CorrespondentJudi Smith
DIASORIN, INC. P.O. BOX 103 Baldwin,  MD  21013
Product CodeMRG  
CFR Regulation Number862.1825 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-09-20
Decision Date2012-01-20
Summary:summary

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