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 |