ClearanceBrief
Panels › Immunology › Product code DBF · Class 2

Ferritin, Antigen, Antiserum, Control

Regulation 866.5340

0510(k)s in 12 months (87 all time)
0recalls in 12 months (7 all time)
7recalls that name a 510(k)
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Top companies in DBF

Decided510(k)Device and applicantCode
Sep 14, 2021K193650LIAISON Ferritin
DiaSorin, Inc.
DBF
Mar 6, 2020K191562Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor
HORIBA ABX SAS, FR
DBF
Aug 31, 2017K171642Atellica IM Ferritin Assay
Siemens Healthcare Diagnostics, Inc.
DBF
Jun 24, 2014K133083DIAZYME FERRITIN ASSAY, DIAZYME FERRITIN CALIBRATOR SET, DIAZYME FERRITIN CONTROL SET
Diazyme Laboratories
DBF
May 24, 2012K121232K-ASSAY (R) FERRITIN REAGENT, K-ASSAY (R) FERRITIN CALIBRATOR
Kamiya Biomedical Company
DBF
Aug 17, 2011K110736ADVIA CHEMISTRY FERRITIN (FRT) METHOD
Siemens Healthcare Diagnostics, Inc.
DBF
Jun 22, 2010K100538TINA-QUANT FERRITIN GEN. 4
Roche Diagnostics
DBF
Dec 11, 2009K092505BECKMAN COULTER FERRITIN REAGENT, MODEL: OSR61203
Beckman Coulter, Inc., IE
DBF
Nov 20, 2006K062746FERRITIN-LATEX, MODELS 1418-2070, 1418-0279
Medicon Hellas S.A, GR
DBF
Mar 13, 2006K053211RDI HSFERRITIN KIT
Reference Diagnostics, Inc.
DBF
Feb 23, 2006K052617FERRITIN LIT ASSAY, CATALOG NO. 7010; FERRITIN CALIBRATOR SET, CATALOG NO. 7510; FERRITIN CONTROLS, LEVEL-L & LEVEL-H,
Good Biotech Corp., TW
DBF
Dec 23, 2005K050944K-ASSAY FERRITIN (2) & FERRITIN CALIBRATOR SET
Kamiya Biomedical Co.
DBF
May 10, 2004K040879QUANTEX FERRITIN
Instrumentation Laboratory CO
DBF
Jul 17, 2003K031650FERRITIN GENERATION 2
Roche Diagnostics Corp.
DBF
Feb 6, 2003K030124OLYMPUS FERRITIN REAGENT
Olympus America, Inc.
DBF
Feb 19, 2002K014293K-ASSAY FERRITIN, K-ASSAY FERRITIN CALIBRATOR SET
Kamiya Biomedical Co.
DBF
Apr 3, 2000K000662RANDOX FERRITIN
Randox Laboratories, Ltd., IE
DBF
Nov 23, 1999K993273N LATEX FERRITIN
Dade Behring, Inc.
DBF
Sep 24, 1999K992517BIOCHECK FERRITIN ELISA MODEL BC-1025
Biocheck, Inc.
DBF
Aug 5, 1999K992157CHIRON DIAGNOSTICS ACS: 180 FERRITIN ASSAY
Chiron Diagnostics Corp.
DBF
Feb 2, 1999K984186NICHOLS ADVANTAGE CHEMILUMINESCENCE FERRITIN IMMUNOASSAY
Nichols Institute Diagnostics
DBF
Dec 14, 1998K983340IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN (FER)REAGENT, IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN CALIBRATOR
Beckman Coulter, Inc.
DBF
Dec 7, 1998K983759ABBOTT ARCHITECT FERRITIN
Abbott Laboratories
DBF
Oct 22, 1998K982714BAYER IMMUNO 1 SYSTEM FERRITIN ASSAY
Bayer Corp.
DBF
Feb 17, 1998K974505AURAFLEX FERRITIN 200 TEST PACK 80500, AURAFLEX FERRITIN CALIBRATOR PACK 80501
Alfa Biotech (Uk) , Ltd., GB
DBF
Oct 22, 1997K973331VITROS IMMUNODIAGNOSTIC PRODUCTS FERRITIN REAGENT PACK (GEM.1340), FERRITIN CALIBRATORS (GEM.C340)
Ortho-Clinical Diagnostics, Inc.
DBF
Sep 12, 1997K973202MODIFICATION OF OPUS FERRITIN TEST SYSTEM
Behring Diagnostics, Inc.
DBF
Jun 24, 1997K970612SEALITE SCIENCES, INC. AQUALITE FERRITIN ASSAY
Sealite Sciences, Inc.
DBF
Dec 2, 1996K963170OLYMPUS FERRITIN IMMUNOTURBIDIMETRIC REAGENT
Olympus America, Inc.
DBF
Jul 5, 1995K951993UBI MAGIWEL FERRITIN QUANTITATIVE
United Biotech, Inc.
DBF
Jun 20, 1995K952286AMERLITE FERRITIN II ASSAY
Johnson & Johnson Clinical Diagnostics, Inc.
DBF
Mar 27, 1995K950707N LATEX FERRITIN
Behring Diagnostics, Inc.
DBF
Jun 21, 1994K935847AXSYM FERRITIN
Abbott Laboratories
DBF
Jan 28, 1994K935528DUPONT ACA(R) PLUS IMMUNOASSAY SYS FERRITIN(FERR) METH
E.I. Dupont DE Nemours & Co., Inc.
DBF
Aug 5, 1993K931576VISTA FERRITIN ASSAY
Syva Co.
DBF
Dec 15, 1992K924858AIA-PACK FER CALIBRATION VERIFICATION TEST SET
Tosoh Medics, Inc.
DBF
Apr 7, 1992K920952VITEK IMMUNODIAG ASSAY SYST(VIDAS) FERRITINE ASSAY
Vitek Systems, Inc.
DBF
Jan 28, 1992K920046MODIFIED FERRITIN ENZYME IMUNOASSAY TEST KIT
Medix Biotech, Inc.
DBF
Apr 5, 1991K911175SRI FERRITIN IMMOENZYMETRIC ASSAY(MAG SOLID-PHASE)
Serono-Baker Diagnostics, Inc.
DBF
Mar 12, 1991K905770CIBA CORNING ACS FERRITIN IMMUNOASSAY
Ciba Corning Diagnostics Corp.
DBF
Nov 29, 1990K904822ELEGANCE FERRITIN ELISA
Bioclone Australia Pty , Ltd.
DBF
Apr 2, 1990K901075LUMATAG(TM) FERRITIN CHEMILUMINESCENCE IMMUNOMET.
London Diagnostics, Inc.
DBF
Dec 4, 1989K896585MODIFIED FERRITIN ENZYME IMMUNOASSAY TEST KIT
Medix Biotech, Inc.
DBF
Oct 17, 1989K895872LAN.0800Q/2800Q
Amersham Corp.
DBF
May 9, 1989K892362AMERLITE FERRITIN ASSAY (ADDITIONAL PROTOCOL)
Amersham Corp.
DBF
Jan 4, 1989K885074AFFINITY(TM) FERRITIN IMMUNIT(TM)
Bd Becton Dickinson Vacutainer Systems Preanalytic
DBF
Dec 27, 1988K884683FERRITIN SEROZYME IMMUNOENZYMETRIC ASSAY
Serono-Baker Diagnostics, Inc.
DBF
Oct 27, 1988K883746MICROMEDIC FERRITIN IRMA KIT
Icn Micromedic Systems
DBF
Jan 27, 1988K874203AMERLITE FERRITIN ASSAY, LAN.0800/1800/2800
Amersham Corp.
DBF
Dec 2, 1987K874572ALLEGRO (TM) FERRITIN IMMUNOASSAY SYSTEM
Nichols Institute Diagnostics
DBF

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