CFM · Class I · 21 CFR 862.1410

FDA Product Code CFM: Bathophenanthroline, Colorimetry, Iron (non-heme)

Leading manufacturers include Abbott Laboratories, Wako Chemicals USA, Inc. and Diagnostic Chemicals, Ltd. (Usa).

21
Total
21
Cleared
40d
Avg days
1979
Since

FDA 510(k) Cleared Bathophenanthroline, Colorimetry, Iron (non-heme) Devices (Product Code CFM)

21 devices
1–21 of 21
Cleared Jan 15, 1999
WAKO L-TYPE FE, WAKO L-TYPE CALIBRATOR
K984119
Wako Chemicals USA, Inc.
Chemistry · 58d
Cleared Jun 08, 1998
IRON
K981581
Abbott Laboratories
Chemistry · 35d
Cleared Sep 08, 1993
UIBC FOR DISCREET RANDOM ACCESS ANALYZER
K932871
Catachem, Inc.
Chemistry · 86d
Cleared Oct 09, 1991
ABBOTT QLUICKSTART IRON TEST, ITEM #5A29
K913705
Em Diagnostic Systems, Inc.
Chemistry · 51d
Cleared Jul 30, 1991
SYNERMED SERUM IRON-600 REAGENT KIT
K912912
Synermed, Inc.
Chemistry · 27d
Cleared Jul 31, 1990
SYNERMED SERUM IRON REAGENT KIT
K902918
Synermed, Inc.
Chemistry · 28d
Cleared Oct 17, 1989
CLINISTAT POTASSIUM REAGENT TEST
K895047
Heraeus Kulzer, Inc.
Chemistry · 69d
Cleared Apr 18, 1989
IRON REAGENT
K891155
Medical Analysis Systems, Inc.
Chemistry · 43d
Cleared Aug 25, 1987
ABBOTT A-GENT IRON REAGENT KIT
K873120
Abbott Laboratories
Chemistry · 15d
Cleared May 23, 1986
TOTAL IRON BINDING CAPACITY PROCEDURE
K861602
Data Medical Associates, Inc.
Chemistry · 24d
Cleared Nov 12, 1985
DART IRON & IRON BINDING CAPACITY REAGENT
K854305
Coulter Electronics, Inc.
Chemistry · 18d
Cleared Jul 12, 1985
DATA CHEM IRON PROCEDURE
K852583
Data Medical Associates, Inc.
Chemistry · 24d
Cleared Aug 07, 1984
SERUM IRON & SERUM IRON BINDING CAPACI
K842155
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 69d
Cleared Aug 07, 1984
SERUM IRON & SERUM IRON BINDING CAPACITY
K842156
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 69d
Cleared Aug 07, 1984
TDX REA IRON DIAGNOSTIC KIT
K842505
Abbott Laboratories
Chemistry · 42d
Cleared Mar 29, 1983
FEB TEST
K830564
Wako Chemicals USA, Inc.
Chemistry · 34d
Cleared Mar 25, 1982
CORNING 902 SODIUM POTASSIUM ANALYZER
K820629
Corning Medical & Scientific
Chemistry · 17d
Cleared Dec 07, 1979
ELVI SERUM IRON
K792406
Volu Sol Medical Industries
Chemistry · 11d

About Product Code CFM - Regulatory Context