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 Roche Diagnostics Corp..

48
Total
48
Cleared
97d
Avg days
1977
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Consistent review times: 84d avg (recent)

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 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 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 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 May 01, 2001
TINA-QUANT SOLUBLE TRANSFERRIN RECEPTOR TEST SYSTEM, HITACHI CATALOG # 2148315
K003064
Roche Diagnostics Corp.
Immunology · 211d
Cleared Feb 04, 2000
DIMENSION TRNF FLEX REAGENT CARTRIDGE
K994294
Dade Behring, Inc.
Immunology · 45d
Cleared Aug 02, 1999
N LATEX STFR REAGENT
K991157
Dade Behring, Inc.
Immunology · 117d
Cleared Nov 04, 1998
TRF
K983167
Abbott Laboratories
Immunology · 55d
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
Cleared Oct 07, 1996
IMMAGE IMMUNOCHEMISTRY SYSTEM TRANSFERRIN (TRF) REAGENT
K963427
Beckman Instruments, Inc.
Immunology · 38d
Cleared Nov 03, 1993
BOEHRINGER MANNHEIM TINA-QUANT TRANSFERRIN ASSAY
K933589
Boehringer Mannheim Corp.
Immunology · 100d
Cleared Oct 07, 1993
BECKMAN TRANSFERRIN KIT
K926272
Beckman Instruments, Inc.
Immunology · 293d
Cleared Jan 17, 1992
IL TEST(TM) TRANSFERRIN (TRF)
K914993
Instrumentation Laboratory CO
Immunology · 71d
Cleared Jun 15, 1987
TINA-QUANT [A] TRANSFERRIN
K871896
Boehringer Mannheim Corp.
Immunology · 31d
Cleared May 14, 1987
PRECIMAT(R) TRANSFERRIN
K871022
Boehringer Mannheim Corp.
Immunology · 59d
Cleared Feb 21, 1986
TDX TRANSFERRIN DIAGNOSTIC KIT
K854416
Abbott Laboratories
Immunology · 109d

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 increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - DDG Product Code

FDA review times for DDG submissions have been consistent, averaging 84 days recently vs 98 days historically.

DDG devices are reviewed by the Immunology panel. Browse all Immunology devices →