FDA.reportPublic FDA data

510(k) K182698

Device
LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON Calprotectin Calibration Verifiers, LIAISON Q.S.E.T. Buffer, LIAISON Q.S.E.T. Device
Applicant
DiaSorin Inc.
510(k) number
K182698
Product code
NXO  
Decision
Substantially Equivalent (SESE)
Decision date
2018-12-26
Date received
2018-09-27
Regulation
866.5180
Classification name
Calprotectin, Fecal
Medical specialty
Immunology
Review panel
Immunology
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 NXO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K232057BÜHLMANN fCAL® turbo and CALEX® CapBühlmann Laboratories AG2024-02-06
K220763ALPCO Calprotectin Immunoturbidimetric AssayALPCO2023-04-13
K213858LIAISON Calprotectin, LIAISON Q.S.E.T. Device PlusDiaSorin, Inc.2022-07-26
K191807ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction DeviceALPCO2019-10-25
K191718Buhlmann fCAL turbo and CALEX CapBuhlmann Laboratories AG2019-09-24
K191589Calprest, EasyCalEurospital S.P.A.2019-07-10
K191592CalprestNG, EasyCalEurospital S.P.A.2019-07-10
K190784BUHLMANN fCAL turboBuhlmann Laboratories AG2019-06-25
K180971QUANTA Flash Calprotectin and Fecal Extraction DeviceInova Diagnostics, Inc.2018-10-16
K181012BUHLMANN fCAL ELISABuhlmann Laboratories AG2018-06-04
K170993QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Flash Calprotectin Extraction BufferInova Diagnostics, Inc.2017-12-22
K160447Calprest NGEurospital S.P.A.2016-11-10
K130945CALPRESTEurospital S.P.A.2014-01-16
DEN060001PHICAL TESTGenova Diagnostics2006-04-26

Legacy Summary#

summary

FDA Review#

Decision Summary