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510(k) K213936

Device
LIAISON MeMed BV, LIAISON MeMed BV Control Set
Applicant
DiaSorin Inc.
510(k) number
K213936
Product code
QPS  
Decision
Substantially Equivalent (SESE)
Decision date
2022-07-14
Date received
2021-12-16
Regulation
866.3215
Classification name
Immunoassay For Host Biomarkers Of Infection
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
John C. Walter
Address
1951 Northwestern Ave. Stillwater MN US 55082 55082

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QPS  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K230944MeMed BVMeMed Diagnostics, Ltd.2023-06-30
K222332MeMed BVMeMed Diagnostics, Ltd.2023-03-23
K210254MeMed BVMeMed Diagnostics, Ltd.2021-09-01

Legacy Summary#

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FDA Review#

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