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510(k) K193650

Device
LIAISON Ferritin
Applicant
DiaSorin, Inc.
510(k) number
K193650
Product code
DBF
Decision
Substantially Equivalent (SESE)
Decision date
2021-09-14
Date received
2019-12-30
Regulation
866.5340
Classification name
Ferritin, Antigen, Antiserum, Control
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 DBF#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K191562Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid FactorHORIBA ABX SAS2020-03-06
K171642Atellica IM Ferritin AssaySiemens Healthcare Diagnostics, Inc.2017-08-31
K133083DIAZYME FERRITIN ASSAY, DIAZYME FERRITIN CALIBRATOR SET, DIAZYME FERRITIN CONTROL SETDiazyme Laboratories2014-06-24
K121232K-ASSAY (R) FERRITIN REAGENT, K-ASSAY (R) FERRITIN CALIBRATORKamiya Biomedical Company2012-05-24
K110736ADVIA CHEMISTRY FERRITIN (FRT) METHODSiemens Healthcare Diagnostics, Inc.2011-08-17
K100538TINA-QUANT FERRITIN GEN. 4Roche Diagnostics2010-06-22
K092505BECKMAN COULTER FERRITIN REAGENT, MODEL: OSR61203Beckman Coulter, Inc.2009-12-11
K062746FERRITIN-LATEX, MODELS 1418-2070, 1418-0279Medicon Hellas S.A2006-11-20
K053211RDI HSFERRITIN KITReference Diagnostics, Inc.2006-03-13
K052617FERRITIN LIT ASSAY, CATALOG NO. 7010; FERRITIN CALIBRATOR SET, CATALOG NO. 7510; FERRITIN CONTROLS, LEVEL-L & LEVEL-H,Good Biotech Corp.2006-02-23
K050944K-ASSAY FERRITIN (2) & FERRITIN CALIBRATOR SETKamiya Biomedical Co.2005-12-23
K040879QUANTEX FERRITINInstrumentation Laboratory CO2004-05-10
K031650FERRITIN GENERATION 2Roche Diagnostics Corp.2003-07-17
K030124OLYMPUS FERRITIN REAGENTOlympus America, Inc.2003-02-06
K014293K-ASSAY FERRITIN, K-ASSAY FERRITIN CALIBRATOR SETKamiya Biomedical Co.2002-02-19