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

FDA 510(k) Number Applicant Device Name Decision Date
K854416 ABBOTT LABORATORIES TDX TRANSFERRIN DIAGNOSTIC KIT 02/21/1986
K983167 ABBOTT LABORATORIES TRF 11/04/1998
K850589 APPLICATIONS LAB SPQ TEST SYSTEM FOR TRANSFERRIN 03/05/1985
K890563 ATLANTIC ANTIBODIES SPQ(TM) ANTIBODY REAGENT SET II FOR TRF 03/03/1989
K080634 BECKMAN COULTER, INC. ACCESS STFR, ACCESS STFR CALIBRATORS, AND ACCESS STFR QC WITH MODELS, A32493, A32494, AND A32495 08/11/2008
K926272 BECKMAN INSTRUMENTS, INC. BECKMAN TRANSFERRIN KIT 10/07/1993
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
K830911 BIOCELL LABORATORIES, INC. RADIAL IMMUNODIFFUSION PLATES 06/10/1983
K933589 BOEHRINGER MANNHEIM CORP. BOEHRINGER MANNHEIM TINA-QUANT TRANSFERRIN ASSAY 11/03/1993
K871022 BOEHRINGER MANNHEIM CORP. PRECIMAT(R) TRANSFERRIN 05/14/1987
K871896 BOEHRINGER MANNHEIM CORP. TINA-QUANT [A] TRANSFERRIN 06/15/1987
K851287 COOPER BIOMEDICAL, INC. RADIAL IMMUNODIFFUSION PLATES TRANSFERRIN 05/24/1985
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
K812492 DAKO CORP. IMMUNOGL. FRCT. OF RABBIT ANTISER.-TRAN 09/23/1981
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
K914993 INSTRUMENTATION LABORATORY CO. IL TEST(TM) TRANSFERRIN (TRF) 01/17/1992
K801434 J.T. BAKER CHEMICAL CO. J.T. BAKER TRANSFERRIN NEPHELOMETRIC ASS 07/08/1980
K873789 KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. QM300 TRANSFERRIN ANTIBODY PACK 10/07/1987
K772253 KALLESTAD LABORATORIES, INC. TRANSFERRIN NEPHELOMETRIC ASSAY 12/22/1977
K993537 KAMIYA BIOMEDICAL CO. K-ASSAY TRANSFERRIN 11/30/1999
K811613 KENT LABORATORIES, INC. 72 DETERMIN. SIZE RADIAL IMMUNOD. TEST 08/12/1981
K813288 NEW ENGLAND IMMUNOLOGY ASSOC. NEIA TRANSFERRIN ENZYMEIMMUNOASSAY 12/17/1981
K884075 ORION DIAGNOSTICA, INC. IMMUNOCHEMICAL DETERMINATION OF TRANSFERRIN 10/19/1988
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
K900875 REAGENTS APPLICATIONS, INC. RAICHEM(TM) SPIA(TM) TRANSFERRIN REAGENT 03/06/1990
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
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
K914390 THE BINDING SITE, LTD. TRANSFERRIN RID KIT 12/09/1991
K063086 THERMO ELECTRON OY TRANSFERRIN, SPECICAL CALIBRATOR, SPECITROL AND SPECITROL HIGH CONTROLS 08/08/2007
K873867 UNIPATH LTD. TRANSFERRIN 10/13/1987
K993162 WAKO CHEMICALS, USA, INC. WAKO TRANSFERRIN, TRANSFERRIN CALIBRATOR 11/12/1999


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