Bathophenanthroline, Colorimetry, Iron (Non-Heme)
The Bathophenanthroline Colorimetry Iron (Non-Heme) Test is a clinical chemistry device that measures non-heme iron concentration in biological specimens using the bathophenanthroline colorimetric method, in which iron reacts with the chelating agent to form a red-colored complex proportional to iron content, used in the evaluation of iron deficiency and iron overload conditions. It is classified as FDA Class 1 (lowest risk), subject only to general controls, and is exempt from premarket notification. The product code is CFM, regulated under 21 CFR 862.1410, within the Clinical Chemistry medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- CFM
- Device Class
- FDA class 1
- Regulation Number
- 862.1410
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 21 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K984119 | WAKO L-TYPE FE, WAKO L-TYPE CALIBRATOR | Jan 15, 1999 | Substantially Equivalent | Wako Chemicals USA, Inc. |
| K981581 | IRON | Jun 08, 1998 | Substantially Equivalent | Abbott Laboratories |
| K932871 | UIBC FOR DISCREET RANDOM ACCESS ANALYZER | Sep 08, 1993 | Substantially Equivalent | Catachem, Inc. |
| K913705 | ABBOTT QLUICKSTART IRON TEST, ITEM #5A29 | Oct 09, 1991 | Substantially Equivalent | Em Diagnostic Systems, Inc. |
| K912912 | SYNERMED SERUM IRON-600 REAGENT KIT | Jul 30, 1991 | Substantially Equivalent | Synermed, Inc. |
| K902918 | SYNERMED SERUM IRON REAGENT KIT | Jul 31, 1990 | Substantially Equivalent | Synermed, Inc. |
| K895047 | CLINISTAT POTASSIUM REAGENT TEST | Oct 17, 1989 | Substantially Equivalent | Heraeus Kulzer, Inc. |
| K891155 | IRON REAGENT | Apr 18, 1989 | Substantially Equivalent | Medical Analysis Systems, Inc. |
| K873120 | ABBOTT A-GENT IRON REAGENT KIT | Aug 25, 1987 | Substantially Equivalent | Abbott Laboratories |
| K861602 | TOTAL IRON BINDING CAPACITY PROCEDURE | May 23, 1986 | Substantially Equivalent | Data Medical Associates, Inc. |
| K854305 | DART IRON & IRON BINDING CAPACITY REAGENT | Nov 12, 1985 | Substantially Equivalent | Coulter Electronics, Inc. |
| K852583 | DATA CHEM IRON PROCEDURE | Jul 12, 1985 | Substantially Equivalent | Data Medical Associates, Inc. |
| K842505 | TDX REA IRON DIAGNOSTIC KIT | Aug 07, 1984 | Substantially Equivalent | Abbott Laboratories |
| K842156 | SERUM IRON & SERUM IRON BINDING CAPACITY | Aug 07, 1984 | Substantially Equivalent | Diagnostic Chemicals, Ltd. (Usa) |
| K842155 | SERUM IRON & SERUM IRON BINDING CAPACI | Aug 07, 1984 | Substantially Equivalent | Diagnostic Chemicals, Ltd. (Usa) |
| K840485 | TOTAL IRON UIBC/TIBC ASSAY | Mar 12, 1984 | Substantially Equivalent | Somas Medical Industries, Inc. |
| K834396 | DIRECT IRON REAGENT SET | Feb 21, 1984 | Substantially Equivalent | Seragen Diagnostics, Inc. |
| K830564 | FEB TEST | Mar 29, 1983 | Substantially Equivalent | Wako Chemicals USA, Inc. |
| K820629 | CORNING 902 SODIUM POTASSIUM ANALYZER | Mar 25, 1982 | Substantially Equivalent | Corning Medical & Scientific |
| K810085 | IRON KIT | Jan 28, 1981 | Substantially Equivalent | Bio-Analytics Laboratories, Inc. |
| K792406 | ELVI SERUM IRON | Dec 07, 1979 | Substantially Equivalent | Volu Sol Medical Industries |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.