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 |