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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