LIAISON® Folate

Acid, Folic, Radioimmunoassay

Diasorin Inc.

The following data is part of a premarket notification filed by Diasorin Inc. with the FDA for Liaison® Folate.

Pre-market Notification Details

Device IDK192586
510k NumberK192586
Device Name:LIAISON® Folate
ClassificationAcid, Folic, Radioimmunoassay
Applicant Diasorin Inc. 1951 Northwestern Ave Stillwater,  MN  55082 -0285
ContactJohn C. Walter
CorrespondentMari Meyer
Diasorin Inc. 1951 Northwestern Ave Stillwater,  MN  55082 -0285
Product CodeCGN  
CFR Regulation Number862.1295 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-19
Decision Date2020-05-06

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