CFMClass I
Bathophenanthroline, Colorimetry, Iron (non-heme)
Clinical Chemistry · 21 CFR 862.1410
MDR events16All time
Recalls0All time
Registered firms4Currently listed
510(k) clearances21All time
Recent MDR events
16 adverse event reports on file
- ALINITY C IRON2Sep 12, 2023MalfunctionAbbott Ireland Diagnostics Division3005094123-2023-00239
- CLINICAL CHEMISTRY IRONOct 7, 2008MalfunctionAbbott Laboratories1415939-2008-00506
- CLINICAL CHEMISTRY IRONOct 7, 2008MalfunctionAbbott Laboratories1415939-2008-00507
- CLINICAL CHEMISTRY IRONSep 17, 2008MalfunctionAbbott Manufacturing, Inc.2018433-2008-00184
- CLINICAL CHEMISTRY IRONSep 17, 2008MalfunctionAbbott Manufacturing, Inc.2018433-2008-00185
- CLINICAL CHEMISTRY IRONSep 11, 2008MalfunctionAbbott Manufacturing, Inc.2018433-2008-00182
- CLINICAL CHEMISTRY IRONMar 18, 2008OtherAbbott Laboratories, Inc.2018433-2008-00031
- CLINICAL CHEMISTRY IRONNov 16, 2007MalfunctionAbbott Manufacturing, Inc.2018433-2007-00244
- CLINICAL CHEMISTRY IRONNov 16, 2007MalfunctionAbbott Manufacturing, Inc.2018433-2007-00243
- CLINICAL CHEMISTRY IRONNov 16, 2007MalfunctionAbbott Manufacturing, Inc.2018433-2007-00242
Event type breakdown
Malfunction15
Other1
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
4 firms currently registered for this product code
510(k) clearances
21 clearances for this product code
- Wako Chemicals USA, Inc.Jan 15, 1999
K984119 · WAKO L-TYPE FE, WAKO L-TYPE CALIBRATOR
- Abbott LaboratoriesJun 8, 1998
K981581 · IRON
- Catachem, Inc.Sep 8, 1993
K932871 · UIBC FOR DISCREET RANDOM ACCESS ANALYZER
- Em Diagnostic Systems, Inc.Oct 9, 1991
K913705 · ABBOTT QLUICKSTART IRON TEST, ITEM #5A29
- Synermed, Inc.Jul 30, 1991
K912912 · SYNERMED SERUM IRON-600 REAGENT KIT
- Synermed, Inc.Jul 31, 1990
K902918 · SYNERMED SERUM IRON REAGENT KIT
- Heraeus Kulzer, Inc.Oct 17, 1989
K895047 · CLINISTAT POTASSIUM REAGENT TEST
- Medical Analysis Systems, Inc.Apr 18, 1989
K891155 · IRON REAGENT