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510(k) K170993

Device
QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Flash Calprotectin Extraction Buffer
Applicant
Inova Diagnostics, Inc.
510(k) number
K170993
Product code
NXO  
Decision
Substantially Equivalent (SESE)
Decision date
2017-12-22
Date received
2017-04-03
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
K180971QUANTA Flash Calprotectin and Fecal Extraction DeviceInova Diagnostics, Inc.2018-10-16
K181012BUHLMANN fCAL ELISABuhlmann Laboratories AG2018-06-04
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