FDA 510(k) Applications for Medical Device Product Code "DDG"
(Transferrin, Antigen, Antiserum, Control)

FDA 510(k) Number Applicant Device Name Decision Date
K983167 ABBOTT LABORATORIES TRF 11/04/1998
K080634 BECKMAN COULTER, INC. ACCESS STFR, ACCESS STFR CALIBRATORS, AND ACCESS STFR QC WITH MODELS, A32493, A32494, AND A32495 08/11/2008
K963427 BECKMAN INSTRUMENTS, INC. IMMAGE IMMUNOCHEMISTRY SYSTEM TRANSFERRIN (TRF) REAGENT 10/07/1996
K963976 BECKMAN INSTRUMENTS, INC. IMMUNOCHEMISTRY SYS URINE TRANSFERRIN REAGENT 03/19/1997
K971958 BECKMAN INSTRUMENTS, INC. SYNCHRON LX SYSTEMS TRANSFERRIN (TRFN) REAGENT 08/20/1997
K972840 BEHRING DIAGNOSTICS, INC. N ANTISERUM TO HUMAN TRANSFERRIN 10/17/1997
K190495 BioSystems S.A. Transferrin 03/16/2020
K964295 CRESTAT DIAGNOSTICS, INC. N-ASSAY TIA TRANSFERRIN TEST KIT 06/16/1997
K994294 DADE BEHRING, INC. DIMENSION TRNF FLEX REAGENT CARTRIDGE 02/04/2000
K063663 DADE BEHRING, INC. DIMENSION VISTA STFR FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL L, M AND H 03/21/2007
K063322 DADE BEHRING, INC. DIMENSION VISTA TRF FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR PROTEIN 1 CONTROL L,CONTROL M, CONTROL H 01/24/2007
K053075 DADE BEHRING, INC. N ANTISERA TO HUMAN TRANSFERRIN 03/16/2006
K991157 DADE BEHRING, INC. N LATEX STFR REAGENT 08/02/1999
K983880 DIASORIN, INC. TRANSFERRIN SPQ III ANTIBODY REAGENT SET 12/18/1998
K063766 GOOD BIOTECH CORP. TRANSFERRIN TIA , CALIBRATOR SET, CONTROL-L,CONTROL-M,CONTROL-H, MODEL# KT-0105-A,CA-0105-A,B,C 04/23/2007
K993537 KAMIYA BIOMEDICAL CO. K-ASSAY TRANSFERRIN 11/30/1999
K042477 Ortho-Clinical Diagnostics, Inc. VITROS CHEMISTRY PRODUCTS TRFRN REAHENT; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 20; VITROS CHEMISTRY PRODUCTS PROTEIN 11/19/2004
K002585 RANDOX LABORATORIES, LTD. RANDOX TRANSFERRIN 02/05/2001
K003064 ROCHE DIAGNOSTICS CORP. TINA-QUANT SOLUBLE TRANSFERRIN RECEPTOR TEST SYSTEM, HITACHI CATALOG # 2148315; INTEGRA CATALOG # 2148323 05/01/2001
K012371 ROCHE DIAGNOSTICS CORP. TINA-QUANT TRANSFERRIN VER.2 09/19/2001
K012393 ROCHE DIAGNOSTICS CORP. TINA-QUANT TRANSFERRIN VER.2 09/19/2001
K182095 Roche Diagnostics Operations (RDO) Tina-quant Transferrin ver.2 (urine application) 11/05/2018
K081299 Siemens Healthcare Diagnostics Inc. DIMENSION VISTA SYSTEM TRF FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA 08/08/2008
K120236 THE BINDING SITE GROUP LTD TRANSFERRIN KIT FOR USE ON THE SPAPLUS 02/13/2013
K011662 THE BINDING SITE, LTD. MININEPH A-1 TRANSFERRIN ANTISERUM, HIGH AND LOW SERUM CONTROL 07/30/2001
K063086 THERMO ELECTRON OY TRANSFERRIN, SPECICAL CALIBRATOR, SPECITROL AND SPECITROL HIGH CONTROLS 08/08/2007
K993162 WAKO CHEMICALS, USA, INC. WAKO TRANSFERRIN, TRANSFERRIN CALIBRATOR 11/12/1999


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