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DBF — Ferritin, Antigen, Antiserum, Control Class II

FDA Device Classification

Classification Details

Product Code
DBF
Device Class
Class II
Regulation Number
866.5340
Submission Type
Review Panel
IM
Medical Specialty
Immunology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K193650diasorinLIAISON FerritinSeptember 14, 2021
K191562horiba abxYumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid FactMarch 6, 2020
K171642siemens healthcare diagnosticsAtellica IM Ferritin AssayAugust 31, 2017
K133083diazyme laboratoriesDIAZYME FERRITIN ASSAY, DIAZYME FERRITIN CALIBRATOR SET, DIAZYME FERRITIN CONTROJune 24, 2014
K121232kamiya biomedicalK-ASSAY (R) FERRITIN REAGENT, K-ASSAY (R) FERRITIN CALIBRATORMay 24, 2012
K110736siemens healthcare diagnosticsADVIA CHEMISTRY FERRITIN (FRT) METHODAugust 17, 2011
K100538roche diagnosticsTINA-QUANT FERRITIN GEN. 4June 22, 2010
K092505beckman coulterBECKMAN COULTER FERRITIN REAGENT, MODEL: OSR61203December 11, 2009
K062746medicon hellasFERRITIN-LATEX, MODELS 1418-2070, 1418-0279November 20, 2006
K053211reference diagnosticsRDI HSFERRITIN KITMarch 13, 2006
K052617good biotechFERRITIN LIT ASSAY, CATALOG NO. 7010; FERRITIN CALIBRATOR SET, CATALOG NO. 7510;February 23, 2006
K050944kamiya biomedicalK-ASSAY FERRITIN (2) & FERRITIN CALIBRATOR SETDecember 23, 2005
K040879instrumentation laboratoryQUANTEX FERRITINMay 10, 2004
K031650roche diagnosticsFERRITIN GENERATION 2July 17, 2003
K030124olympus americaOLYMPUS FERRITIN REAGENTFebruary 6, 2003
K014293kamiya biomedicalK-ASSAY FERRITIN, K-ASSAY FERRITIN CALIBRATOR SETFebruary 19, 2002
K000662randox laboratoriesRANDOX FERRITINApril 3, 2000
K993273dade behringN LATEX FERRITINNovember 23, 1999
K992517biocheckBIOCHECK FERRITIN ELISA MODEL BC-1025September 24, 1999
K992157chiron diagnosticsCHIRON DIAGNOSTICS ACS: 180 FERRITIN ASSAYAugust 5, 1999