LIAISON 25 OH VITAMIN D TOTAL CALIBRATION VERIFIERS, MODEL: 310603

Single (specified) Analyte Controls (assayed And Unassayed)

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 Calibration Verifiers, Model: 310603.

Pre-market Notification Details

Device IDK090104
510k NumberK090104
Device Name:LIAISON 25 OH VITAMIN D TOTAL CALIBRATION VERIFIERS, MODEL: 310603
ClassificationSingle (specified) Analyte Controls (assayed And Unassayed)
Applicant DIASORIN, INC. 1951 NORTHWESTERN AVE. Stillwater,  MN  55082 -0285
ContactKelly R Sauer
CorrespondentKelly R Sauer
DIASORIN, INC. 1951 NORTHWESTERN AVE. Stillwater,  MN  55082 -0285
Product CodeJJX  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-01-15
Decision Date2009-09-09
Summary:summary

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