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
Stable submission activity - 0 submissions in the last 2 years

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 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 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 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 Oct 22, 1997
VITROS IMMUNODIAGNOSTIC PRODUCTS FERRITIN REAGENT PACK (GEM.1340), FERRITIN CALIBRATORS (GEM.C340)
K973331
Ortho-Clinical Diagnostics, Inc.
Immunology · 48d
Cleared Sep 12, 1997
MODIFICATION OF OPUS FERRITIN TEST SYSTEM
K973202
Behring Diagnostics, Inc.
Immunology · 66d
Cleared Dec 02, 1996
OLYMPUS FERRITIN IMMUNOTURBIDIMETRIC REAGENT
K963170
Olympus America, Inc.
Immunology · 110d
Cleared Mar 27, 1995
N LATEX FERRITIN
K950707
Behring Diagnostics, Inc.
Immunology · 40d
Cleared Jun 21, 1994
AXSYM FERRITIN
K935847
Abbott Laboratories
Immunology · 195d
Cleared Jan 28, 1994
DUPONT ACA(R) PLUS IMMUNOASSAY SYS FERRITIN(FERR) METH
K935528
E.I. Dupont DE Nemours & Co., Inc.
Immunology · 73d

About Product Code DBF - Regulatory Context

510(k) Submission Activity

87 total 510(k) submissions under product code DBF since 1977, with 87 receiving FDA clearance (average review time: 67 days).

Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.