LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set

Helicobacter Pylori

DiaSorin Inc.

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

Pre-market Notification Details

Device IDK181464
510k NumberK181464
Device Name:LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set
ClassificationHelicobacter Pylori
Applicant DiaSorin Inc. 1951 Northwestern Ave. Stillwater,  MN  55082 -0285
ContactJohn C. Walter
CorrespondentSandra Zimniewicz
DiaSorin Inc. 1951 Northwestern Ave. Stillwater,  MN  55082 -0285
Product CodeLYR  
Subsequent Product CodeJJF
Subsequent Product CodeJJX
CFR Regulation Number866.3110 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-06-04
Decision Date2018-08-31
Summary:summary

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