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510(k) K232057

Device
BÜHLMANN fCAL® turbo and CALEX® Cap
Applicant
Bühlmann Laboratories AG
510(k) number
K232057
Product code
NXO
Decision
Substantially Equivalent (SESE)
Decision date
2024-02-06
Date received
2023-07-11
Regulation
866.5180
Classification name
Calprotectin, Fecal
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Laura Zurbrugg
Address
Baselstrasse 55 Schönenbuch CH 4124 4124

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
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
K182698LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON Calprotectin Calibration Verifiers, LIAISON Q.S.E.T. Buffer, LIAISON Q.S.E.T. DeviceDiaSorin, Inc.2018-12-26
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