LIASON XL1,25 DIHYDROXYVITAMIN D; CONTROL SET, CALIBRATION VERIFIERS

System, Test, Vitamin D

DiaSorin Inc.

The following data is part of a premarket notification filed by Diasorin Inc. with the FDA for Liason Xl1,25 Dihydroxyvitamin D; Control Set, Calibration Verifiers.

Pre-market Notification Details

Device IDK141463
510k NumberK141463
Device Name:LIASON XL1,25 DIHYDROXYVITAMIN D; CONTROL SET, CALIBRATION VERIFIERS
ClassificationSystem, Test, Vitamin D
Applicant DiaSorin Inc. 1951 NORTHWESTERN AVENUE Stillwater,  MN  55082 -0285
ContactCarol A Depouw
CorrespondentCarol A Depouw
DiaSorin Inc. 1951 NORTHWESTERN AVENUE Stillwater,  MN  55082 -0285
Product CodeMRG  
CFR Regulation Number862.1825 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-06-03
Decision Date2014-12-10
Summary:summary

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