DBF · Class II · 21 CFR 866.5340

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

Leading manufacturers include Diagnostic Products Corp., Abbott Laboratories and Bd Becton Dickinson Vacutainer Systems Preanalytic.

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 Dec 11, 2009
BECKMAN COULTER FERRITIN REAGENT, MODEL: OSR61203
K092505
Beckman Coulter, Inc.
Immunology · 119d
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 Nov 23, 1999
N LATEX FERRITIN
K993273
Dade Behring, Inc.
Immunology · 54d
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 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
Cleared Aug 05, 1993
VISTA FERRITIN ASSAY
K931576
Syva Co.
Immunology · 128d
Cleared Jan 04, 1989
AFFINITY(TM) FERRITIN IMMUNIT(TM)
K885074
Bd Becton Dickinson Vacutainer Systems Preanalytic
Immunology · 27d
Cleared Nov 25, 1987
IRMA-COUNT FERRITIN W/MONO. ANTIBODIES RKFE1,2,5
K874031
Diagnostic Products Corp.
Immunology · 54d
Cleared Mar 12, 1987
FERRITIN MAB SOLID PHASE COMPONENT SYSTEM
K870570
Bd Becton Dickinson Vacutainer Systems Preanalytic
Immunology · 30d
Cleared Feb 10, 1987
COAT-A-COUNT IRMA FERRITIN KIT AND ITS COMPONENTS
K870107
Diagnostic Products Corp.
Immunology · 29d
Cleared Jan 16, 1987
BECKMAN EPSILON(TM) FERRITIN TEST KIT
K864437
Beckman Instruments, Inc.
Immunology · 65d
Cleared Oct 01, 1986
QUANTIMUNE(R) FERRITIN IRMA
K863487
Bio-Rad
Immunology · 22d
Cleared Mar 28, 1986
ENZYMUN-TEST FERRITIN
K860137
Boehringer Mannheim Corp.
Immunology · 73d
Cleared Aug 20, 1980
FERRIZYME FERRITIN ENZYME IMMUNOASSAY
K801676
Abbott Laboratories
Immunology · 29d
Cleared Aug 13, 1980
FERRITIN RIA KIT
K801580
Diagnostic Products Corp.
Immunology · 34d

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.