ClearanceBrief
Panels › Immunology › Product code NXO · Class 2

Calprotectin, Fecal

Regulation 866.5180

0510(k)s in 12 months (15 all time)
2recalls in 12 months (3 all time)
1recalls that name a 510(k)
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Top companies in NXO

Company510(k)sRecalls
Eurospital S.P.A.40
Buhlmann Laboratories AG30
DiaSorin, Inc.21
ALPCO20
GET TESTED INTERNATIONAL AB02
Inova Diagnostics, Inc.20
Bühlmann Laboratories AG10
Genova Diagnostics10
Decided510(k)Device and applicantCode
Feb 6, 2024K232057BÜHLMANN fCAL® turbo and CALEX® Cap
Bühlmann Laboratories AG, CH
NXO
Apr 13, 2023K220763ALPCO Calprotectin Immunoturbidimetric Assay
ALPCO
NXO
Jul 26, 2022K213858LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus
DiaSorin, Inc.
NXO
Oct 25, 2019K191807ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction Device
ALPCO
NXO
Sep 24, 2019K191718Buhlmann fCAL turbo and CALEX Cap
Buhlmann Laboratories AG, CH
NXO
Jul 10, 2019K191592CalprestNG, EasyCal
Eurospital S.P.A., IT
NXO
Jul 10, 2019K191589Calprest, EasyCal
Eurospital S.P.A., IT
NXO
Jun 25, 2019K190784BUHLMANN fCAL turbo
Buhlmann Laboratories AG, CH
NXO
Dec 26, 2018K182698LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON Calprotectin Calibration Verifiers, LIAISON Q.S.E.T. Buf
DiaSorin, Inc.
NXO
Oct 16, 2018K180971QUANTA Flash Calprotectin and Fecal Extraction Device
Inova Diagnostics, Inc.
NXO
Jun 4, 2018K181012BUHLMANN fCAL ELISA
Buhlmann Laboratories AG, CH
NXO
Dec 22, 2017K170993QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Fl
Inova Diagnostics, Inc.
NXO
Nov 10, 2016K160447Calprest NG
Eurospital S.P.A., IT
NXO
Jan 16, 2014K130945CALPREST
Eurospital S.P.A.
NXO
Apr 26, 2006DEN060001PHICAL TEST
Genova Diagnostics
NXO

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