FDA 510(k) Applications for Medical Device Product Code "CFM"
(Bathophenanthroline, Colorimetry, Iron (Non-Heme))

FDA 510(k) Number Applicant Device Name Decision Date
K873120 ABBOTT LABORATORIES ABBOTT A-GENT IRON REAGENT KIT 08/25/1987
K981581 ABBOTT LABORATORIES IRON 06/08/1998
K842505 ABBOTT LABORATORIES TDX REA IRON DIAGNOSTIC KIT 08/07/1984
K810085 BIO-ANALYTICS LABORATORIES, INC. IRON KIT 01/28/1981
K932871 CATACHEM, INC. UIBC FOR DISCREET RANDOM ACCESS ANALYZER 09/08/1993
K820629 CORNING MEDICAL & SCIENTIFIC CORNING 902 SODIUM POTASSIUM ANALYZER 03/25/1982
K854305 COULTER ELECTRONICS, INC. DART IRON & IRON BINDING CAPACITY REAGENT 11/12/1985
K852583 DATA MEDICAL ASSOCIATES, INC. DATA CHEM IRON PROCEDURE 07/12/1985
K861602 DATA MEDICAL ASSOCIATES, INC. TOTAL IRON BINDING CAPACITY PROCEDURE 05/23/1986
K842155 DIAGNOSTIC CHEMICALS, LTD. (USA) SERUM IRON & SERUM IRON BINDING CAPACI 08/07/1984
K842156 DIAGNOSTIC CHEMICALS, LTD. (USA) SERUM IRON & SERUM IRON BINDING CAPACITY 08/07/1984
K913705 EM DIAGNOSTIC SYSTEMS, INC. ABBOTT QLUICKSTART IRON TEST, ITEM #5A29 10/09/1991
K895047 HERAEUS KULZER, INC. CLINISTAT POTASSIUM REAGENT TEST 10/17/1989
K891155 MEDICAL ANALYSIS SYSTEMS, INC. IRON REAGENT 04/18/1989
K834396 SERAGEN DIAGNOSTICS, INC. DIRECT IRON REAGENT SET 02/21/1984
K840485 SOMAS MEDICAL INDUSTRIES, INC. TOTAL IRON UIBC/TIBC ASSAY 03/12/1984
K902918 SYNERMED, INC. SYNERMED SERUM IRON REAGENT KIT 07/31/1990
K912912 SYNERMED, INC. SYNERMED SERUM IRON-600 REAGENT KIT 07/30/1991
K792406 VOLU SOL MEDICAL INDUSTRIES ELVI SERUM IRON 12/07/1979
K830564 WAKO CHEMICALS, USA, INC. FEB TEST 03/29/1983
K984119 WAKO CHEMICALS, USA, INC. WAKO L-TYPE FE, WAKO L-TYPE CALIBRATOR 01/15/1999


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