DDG · Class II · 21 CFR 866.5880

FDA Product Code DDG: Transferrin, Antigen, Antiserum, Control

Leading manufacturers include Dade Behring, Inc., Beckman Instruments, Inc. and Boehringer Mannheim Corp..

48
Total
48
Cleared
97d
Avg days
1977
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Transferrin, Antigen, Antiserum, Control Devices (Product Code DDG)

48 devices
1–24 of 48
Cleared Jul 03, 2024
Access sTfR
K240987
Beckman Coulter, Inc.
Immunology · 84d
Cleared Mar 16, 2020
Transferrin
K190495
Biosystems S.A.
Immunology · 382d
Cleared Nov 05, 2018
Tina-quant Transferrin ver.2 (urine application)
K182095
Roche Diagnostics Operations (Rdo)
Immunology · 94d
Cleared Feb 13, 2013
TRANSFERRIN KIT FOR USE ON THE SPAPLUS
K120236
The Binding Site Group , Ltd.
Immunology · 384d
Cleared Aug 11, 2008
ACCESS STFR, ACCESS STFR CALIBRATORS, AND ACCESS STFR QC WITH MODELS, A32493, A32494, AND A32495
K080634
Beckman Coulter, Inc.
Immunology · 158d
Cleared Aug 08, 2008
DIMENSION VISTA SYSTEM TRF FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA
K081299
Siemens Healthcare Diagnostics, Inc.
Immunology · 92d
Cleared Mar 21, 2007
DIMENSION VISTA STFR FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL L, M AND H
K063663
Dade Behring, Inc.
Chemistry · 103d
Cleared Jan 24, 2007
DIMENSION VISTA TRF FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR PROTEIN 1 CONTROL L,CONTROL M, CONTROL H
K063322
Dade Behring, Inc.
Immunology · 82d
Cleared Mar 16, 2006
N ANTISERA TO HUMAN TRANSFERRIN
K053075
Dade Behring, Inc.
Immunology · 135d
Cleared Nov 19, 2004
VITROS CHEMISTRY PRODUCTS TRFRN REAHENT
K042477
Ortho-Clinical Diagnostics, Inc.
Chemistry · 67d
Cleared Sep 19, 2001
TINA-QUANT TRANSFERRIN VER.2
K012371
Roche Diagnostics Corp.
Immunology · 55d
Cleared Sep 19, 2001
TINA-QUANT TRANSFERRIN VER.2
K012393
Roche Diagnostics Corp.
Immunology · 54d
Cleared Jul 30, 2001
MININEPH A-1 TRANSFERRIN ANTISERUM, HIGH AND LOW SERUM CONTROL
K011662
The Binding Site, Ltd.
Immunology · 62d
Cleared May 01, 2001
TINA-QUANT SOLUBLE TRANSFERRIN RECEPTOR TEST SYSTEM, HITACHI CATALOG # 2148315
K003064
Roche Diagnostics Corp.
Immunology · 211d
Cleared Feb 05, 2001
RANDOX TRANSFERRIN
K002585
Randox Laboratories, Ltd.
Chemistry · 168d
Cleared Feb 04, 2000
DIMENSION TRNF FLEX REAGENT CARTRIDGE
K994294
Dade Behring, Inc.
Immunology · 45d
Cleared Nov 30, 1999
K-ASSAY TRANSFERRIN
K993537
Kamiya Biomedical Co.
Immunology · 42d
Cleared Nov 12, 1999
WAKO TRANSFERRIN, TRANSFERRIN CALIBRATOR
K993162
Wako Chemicals USA, Inc.
Immunology · 51d
Cleared Aug 02, 1999
N LATEX STFR REAGENT
K991157
Dade Behring, Inc.
Immunology · 117d
Cleared Dec 18, 1998
TRANSFERRIN SPQ III ANTIBODY REAGENT SET
K983880
DiaSorin, Inc.
Immunology · 46d
Cleared Nov 04, 1998
TRF
K983167
Abbott Laboratories
Immunology · 55d
Cleared Oct 17, 1997
N ANTISERUM TO HUMAN TRANSFERRIN
K972840
Behring Diagnostics, Inc.
Immunology · 77d
Cleared Aug 20, 1997
SYNCHRON LX SYSTEMS TRANSFERRIN (TRFN) REAGENT
K971958
Beckman Instruments, Inc.
Immunology · 84d
Cleared Mar 19, 1997
IMMUNOCHEMISTRY SYS URINE TRANSFERRIN REAGENT
K963976
Beckman Instruments, Inc.
Immunology · 166d

About Product Code DDG - Regulatory Context

510(k) Submission Activity

48 total 510(k) submissions under product code DDG since 1977, with 48 receiving FDA clearance (average review time: 97 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.