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510(k) K180971

Device
QUANTA Flash Calprotectin And Fecal Extraction Device
Applicant
Inova Diagnostics, Inc.
510(k) number
K180971
Product code
NXO  
Decision
Substantially Equivalent (SESE)
Decision date
2018-10-16
Date received
2018-04-13
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
Roger Albesa
Address
9900 Old Grove Rd. San Diego CA US 92131 92131

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
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
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