FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K991666 |
A.P. TOTAL CARE, INC. |
TIBC, PRODUCT NO'S 123-0, 123-02, FE109-01, FE109-02 |
06/30/1999 |
K991244 |
A.P. TOTAL CARE, INC. |
TOTAL IRON, MODELS FE 109-01, FE 109-02 |
05/25/1999 |
K981279 |
ABBOTT LABORATORIES |
TIBC |
05/20/1998 |
K981654 |
ABBOTT LABORATORIES |
TIBC |
07/22/1998 |
K982041 |
ABBOTT LABORATORIES |
UIBC |
07/30/1998 |
K113438 |
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. |
ACE DIRECT TOTALIRON-BINDING CAPACITY (TIBC) REAGENT, ACE SERUM IRON REAGENT, ACE LIPASE REAGENT |
06/01/2012 |
K012340 |
BAYER CORP. |
BAYER ADVIA SYSTEM; UNSATURATED IRON BINDING CAPACITY (UIBC) |
10/01/2001 |
K960485 |
BECKMAN INSTRUMENTS, INC. |
SYNCHRON SYSTEMS IRON (FE)/TOTAL IRON BINDING CAPACITY REAGENTS |
05/10/1996 |
K994115 |
DADE BEHRING, INC. |
TOTAL IRON BINDING CAPACITY (IBCT) FLEX REAGENT CARTRIDGE |
01/28/2000 |
K961587 |
DIAGNOSTIC CHEMICALS LTD. |
IRON (TOTAL) ASSAY CATALOGUE NO. 102-10, 102-25 |
08/27/1996 |
K963116 |
DIAGNOSTIC CHEMICALS LTD. |
UNSATURATED IRON BINDING CAPACITY (UIBC) ASSAY |
08/20/1996 |
K955139 |
OLYMPUS AMERICA, INC. |
OLYMPUS UNSATURATED IRON BINDING CAPACITY REAGENT |
02/12/1996 |
K041793 |
OLYMPUS AMERICA, INC. |
OLYMPUS UNSATURATED IRON BINDING CAPCITY REAGENT, OSR6124/0SR6524 |
07/16/2004 |
K052867 |
Ortho-Clinical Diagnostics, Inc. |
VITROS CHEMISTRY PRODUCTS DTIBC REAGENT |
12/23/2005 |
K061464 |
Ortho-Clinical Diagnostics, Inc. |
VITROS CHEMISTRY PRODUCTS TIBC KIT, MODEL 886 7541; CALIBRATOR KIT 4, MODEL 120 4668 |
06/15/2006 |
K974604 |
RANDOX LABORATORIES, LTD. |
RANDOX IRON |
01/06/1998 |
K000781 |
REFERENCE DIAGNOSTICS, INC. |
DIRECT TIBC KIT |
05/02/2000 |
K990216 |
REFERENCE DIAGNOSTICS, INC. |
MAGNETIC TIBC KIT |
02/16/1999 |
K013102 |
WIENER LABORATORIES S.A.I.C. |
WIENER LAB. FER-COLOR TRANSFERRINA, MODEL AUX. REAGENTS FOR 25 SAMPLES CAT. 1492002 |
11/13/2001 |