CFM · Bathophenanthroline, Colorimetry, Iron (Non-Heme)
Clinical Chemistry · 21 CFR 862.1410 · Class 1
Overview
| Product Code | CFM |
|---|---|
| Device Name | Bathophenanthroline, Colorimetry, Iron (Non-Heme) |
| Regulation | 21 CFR 862.1410 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
An iron (non-heme) test system is a device intended to measure iron (non-heme) in serum and plasma. Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia, hemochromatosis (a disease associated with widespread deposit in the tissues of two iron-containing pigments, hemosiderin and hemofuscin, and characterized by pigmentation of the skin), and chronic renal disease.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
Recent Cleared Devices (20 of 21)
Showing 20 most recent of 21 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K984119 | WAKO L-TYPE FE, WAKO L-TYPE CALIBRATOR | Wako Chemicals USA, Inc. | Jan 15, 1999 | SESE |
| K981581 | IRON | Abbott Laboratories | Jun 8, 1998 | SESE |
| K932871 | UIBC FOR DISCREET RANDOM ACCESS ANALYZER | Catachem, Inc. | Sep 8, 1993 | SESE |
| K913705 | ABBOTT QLUICKSTART IRON TEST, ITEM #5A29 | Em Diagnostic Systems, Inc. | Oct 9, 1991 | SESE |
| K912912 | SYNERMED SERUM IRON-600 REAGENT KIT | Synermed, Inc. | Jul 30, 1991 | SESE |
| K902918 | SYNERMED SERUM IRON REAGENT KIT | Synermed, Inc. | Jul 31, 1990 | SESE |
| K895047 | CLINISTAT POTASSIUM REAGENT TEST | Heraeus Kulzer, Inc. | Oct 17, 1989 | SESE |
| K891155 | IRON REAGENT | Medical Analysis Systems, Inc. | Apr 18, 1989 | SESE |
| K873120 | ABBOTT A-GENT IRON REAGENT KIT | Abbott Laboratories | Aug 25, 1987 | SESE |
| K861602 | TOTAL IRON BINDING CAPACITY PROCEDURE | Data Medical Associates, Inc. | May 23, 1986 | SESE |
| K854305 | DART IRON & IRON BINDING CAPACITY REAGENT | Coulter Electronics, Inc. | Nov 12, 1985 | SESE |
| K852583 | DATA CHEM IRON PROCEDURE | Data Medical Associates, Inc. | Jul 12, 1985 | SESE |
| K842505 | TDX REA IRON DIAGNOSTIC KIT | Abbott Laboratories | Aug 7, 1984 | SESE |
| K842156 | SERUM IRON & SERUM IRON BINDING CAPACITY | Diagnostic Chemicals, Ltd. (Usa) | Aug 7, 1984 | SESE |
| K842155 | SERUM IRON & SERUM IRON BINDING CAPACI | Diagnostic Chemicals, Ltd. (Usa) | Aug 7, 1984 | SESE |
| K840485 | TOTAL IRON UIBC/TIBC ASSAY | Somas Medical Industries, Inc. | Mar 12, 1984 | SESE |
| K834396 | DIRECT IRON REAGENT SET | Seragen Diagnostics, Inc. | Feb 21, 1984 | SESE |
| K830564 | FEB TEST | Wako Chemicals USA, Inc. | Mar 29, 1983 | SESE |
| K820629 | CORNING 902 SODIUM POTASSIUM ANALYZER | Corning Medical & Scientific | Mar 25, 1982 | SESE |
| K810085 | IRON KIT | Bio-Analytics Laboratories, Inc. | Jan 28, 1981 | SESE |
Top Applicants
- Abbott Laboratories — 3 clearances
- Data Medical Associates, Inc. — 2 clearances
- Diagnostic Chemicals, Ltd. (Usa) — 2 clearances
- Synermed, Inc. — 2 clearances
- Wako Chemicals USA, Inc. — 2 clearances
