LIAISON MeMed BV, LIAISON MeMed BV Control Set

Immunoassay For Host Biomarkers Of Infection

DiaSorin Inc.

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

Pre-market Notification Details

Device IDK213936
510k NumberK213936
Device Name:LIAISON MeMed BV, LIAISON MeMed BV Control Set
ClassificationImmunoassay For Host Biomarkers Of Infection
Applicant DiaSorin Inc. 1951 Northwestern Avenue Stillwater,  MN  55082 -0285
ContactJohn C. Walter
CorrespondentEmily Peterson
DiaSorin Inc. 1951 Northwestern Avenue Stillwater,  MN  55082 -0285
Product CodeQPS  
CFR Regulation Number866.3215 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-12-16
Decision Date2022-07-14

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08056771602976 K213936 000
08056771602969 K213936 000

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