DBF · Class II · 21 CFR 866.5340

FDA Product Code DBF: Ferritin, Antigen, Antiserum, Control

Leading manufacturers include Amersham Corp., Diagnostic Products Corp. and Abbott Laboratories.

87
Total
87
Cleared
67d
Avg days
1977
Since

FDA 510(k) Cleared Ferritin, Antigen, Antiserum, Control Devices (Product Code DBF)

87 devices
1–24 of 87
Cleared Sep 14, 2021
LIAISON Ferritin
K193650
DiaSorin, Inc.
Immunology · 624d
Cleared Mar 06, 2020
Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor
K191562
HORIBA ABX SAS
Immunology · 267d
Cleared Aug 31, 2017
Atellica IM Ferritin Assay
K171642
Siemens Healthcare Diagnostics, Inc.
Immunology · 90d
Cleared Jun 24, 2014
DIAZYME FERRITIN ASSAY, DIAZYME FERRITIN CALIBRATOR SET, DIAZYME FERRITIN CONTROL SET
K133083
Diazyme Laboratories
Immunology · 267d
Cleared May 24, 2012
K-ASSAY (R) FERRITIN REAGENT, K-ASSAY (R) FERRITIN CALIBRATOR
K121232
Kamiya Biomedical Company
Immunology · 30d
Cleared Aug 17, 2011
ADVIA CHEMISTRY FERRITIN (FRT) METHOD
K110736
Siemens Healthcare Diagnostics, Inc.
Immunology · 154d
Cleared Jun 22, 2010
TINA-QUANT FERRITIN GEN. 4
K100538
Roche Diagnostics
Immunology · 117d
Cleared Dec 11, 2009
BECKMAN COULTER FERRITIN REAGENT, MODEL: OSR61203
K092505
Beckman Coulter, Inc.
Immunology · 119d
Cleared Mar 13, 2006
RDI HSFERRITIN KIT
K053211
Reference Diagnostics, Inc.
Immunology · 117d
Cleared Dec 23, 2005
K-ASSAY FERRITIN (2) & FERRITIN CALIBRATOR SET
K050944
Kamiya Biomedical Co.
Immunology · 253d
Cleared May 10, 2004
QUANTEX FERRITIN
K040879
Instrumentation Laboratory CO
Immunology · 35d
Cleared Jul 17, 2003
FERRITIN GENERATION 2
K031650
Roche Diagnostics Corp.
Immunology · 50d
Cleared Feb 06, 2003
OLYMPUS FERRITIN REAGENT
K030124
Olympus America, Inc.
Immunology · 23d
Cleared Feb 19, 2002
K-ASSAY FERRITIN, K-ASSAY FERRITIN CALIBRATOR SET
K014293
Kamiya Biomedical Co.
Immunology · 53d
Cleared Apr 03, 2000
RANDOX FERRITIN
K000662
Randox Laboratories, Ltd.
Immunology · 35d
Cleared Nov 23, 1999
N LATEX FERRITIN
K993273
Dade Behring, Inc.
Immunology · 54d
Cleared Sep 24, 1999
BIOCHECK FERRITIN ELISA MODEL BC-1025
K992517
Biocheck, Inc.
Immunology · 58d
Cleared Aug 05, 1999
CHIRON DIAGNOSTICS ACS: 180 FERRITIN ASSAY
K992157
Chiron Diagnostics Corp.
Immunology · 41d
Cleared Feb 02, 1999
NICHOLS ADVANTAGE CHEMILUMINESCENCE FERRITIN IMMUNOASSAY
K984186
Nichols Institute Diagnostics
Immunology · 71d
Cleared Dec 14, 1998
IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN (FER)REAGENT, IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN CALIBRATOR
K983340
Beckman Coulter, Inc.
Immunology · 82d
Cleared Dec 07, 1998
ABBOTT ARCHITECT FERRITIN
K983759
Abbott Laboratories
Immunology · 42d
Cleared Oct 22, 1998
BAYER IMMUNO 1 SYSTEM FERRITIN ASSAY
K982714
Bayer Corp.
Immunology · 79d
Cleared Feb 17, 1998
AURAFLEX FERRITIN 200 TEST PACK 80500, AURAFLEX FERRITIN CALIBRATOR PACK 80501
K974505
Alfa Biotech (Uk) , Ltd.
Immunology · 78d
Cleared Oct 22, 1997
VITROS IMMUNODIAGNOSTIC PRODUCTS FERRITIN REAGENT PACK (GEM.1340), FERRITIN CALIBRATORS (GEM.C340)
K973331
Ortho-Clinical Diagnostics, Inc.
Immunology · 48d

About Product Code DBF - Regulatory Context