LIAISON XL Zika Capture IgM II And LIAISON XL Zika Capture IgM II Control Set

Zika Virus Serological Reagents

DiaSorin Inc.

The following data is part of a premarket notification filed by Diasorin Inc. with the FDA for Liaison Xl Zika Capture Igm Ii And Liaison Xl Zika Capture Igm Ii Control Set.

Pre-market Notification Details

Device IDK192046
510k NumberK192046
Device Name:LIAISON XL Zika Capture IgM II And LIAISON XL Zika Capture IgM II Control Set
ClassificationZika Virus Serological Reagents
Applicant DiaSorin Inc. 1951 Northwestern Ave. Stillwater,  MN  55082 -0285
ContactJohn C. Walter
CorrespondentSandra Zimniewicz
DiaSorin Inc. 1951 Northwestern Avenue Stillwater,  MN  55082 -0285
Product CodeQFO  
CFR Regulation Number866.3935 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-07-31
Decision Date2019-10-28
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08056771602648 K192046 000
08056771602624 K192046 000

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