LIAISON RUBELLA IGM, LIAISON CONTROL RUBELLA IGM

Enzyme Linked Immunoabsorbent Assay, Rubella

DIASORIN, INC.

The following data is part of a premarket notification filed by Diasorin, Inc. with the FDA for Liaison Rubella Igm, Liaison Control Rubella Igm.

Pre-market Notification Details

Device IDK122397
510k NumberK122397
Device Name:LIAISON RUBELLA IGM, LIAISON CONTROL RUBELLA IGM
ClassificationEnzyme Linked Immunoabsorbent Assay, Rubella
Applicant DIASORIN, INC. 1951 NORTHWESTERN AVE. Stillwater,  MN  55082 -0285
ContactCarol A Depouw
CorrespondentCarol A Depouw
DIASORIN, INC. 1951 NORTHWESTERN AVE. Stillwater,  MN  55082 -0285
Product CodeLFX  
CFR Regulation Number866.3510 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-08-07
Decision Date2012-09-06
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.