FDA 510(k) Applications for Medical Device Product Code "JMO"
(Ferrozine (Colorimetric) Iron Binding Capacity)

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


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