Browse hierarchy: [Clinical Chemistry (CH)](/submissions/CH) → [Subpart B — Clinical Chemistry Test Systems](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems) → [21 CFR 862.1410](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1410) → CFM — Bathophenanthroline, Colorimetry, Iron (Non-Heme) # CFM · Bathophenanthroline, Colorimetry, Iron (Non-Heme) _Clinical Chemistry · 21 CFR 862.1410 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFM ## Overview - **Product Code:** CFM - **Device Name:** Bathophenanthroline, Colorimetry, Iron (Non-Heme) - **Regulation:** [21 CFR 862.1410](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1410) - **Device Class:** 1 - **Review Panel:** [Clinical Chemistry](/submissions/CH) ## 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](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFM/K984119.md) | WAKO L-TYPE FE, WAKO L-TYPE CALIBRATOR | Wako Chemicals USA, Inc. | Jan 15, 1999 | SESE | | [K981581](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFM/K981581.md) | IRON | Abbott Laboratories | Jun 8, 1998 | SESE | | [K932871](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFM/K932871.md) | UIBC FOR DISCREET RANDOM ACCESS ANALYZER | Catachem, Inc. | Sep 8, 1993 | SESE | | [K913705](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFM/K913705.md) | ABBOTT QLUICKSTART IRON TEST, ITEM #5A29 | Em Diagnostic Systems, Inc. | Oct 9, 1991 | SESE | | [K912912](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFM/K912912.md) | SYNERMED SERUM IRON-600 REAGENT KIT | Synermed, Inc. | Jul 30, 1991 | SESE | | [K902918](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFM/K902918.md) | SYNERMED SERUM IRON REAGENT KIT | Synermed, Inc. | Jul 31, 1990 | SESE | | [K895047](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFM/K895047.md) | CLINISTAT POTASSIUM REAGENT TEST | Heraeus Kulzer, Inc. | Oct 17, 1989 | SESE | | [K891155](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFM/K891155.md) | IRON REAGENT | Medical Analysis Systems, Inc. | Apr 18, 1989 | SESE | | [K873120](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFM/K873120.md) | ABBOTT A-GENT IRON REAGENT KIT | Abbott Laboratories | Aug 25, 1987 | SESE | | [K861602](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFM/K861602.md) | TOTAL IRON BINDING CAPACITY PROCEDURE | Data Medical Associates, Inc. | May 23, 1986 | SESE | | [K854305](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFM/K854305.md) | DART IRON & IRON BINDING CAPACITY REAGENT | Coulter Electronics, Inc. | Nov 12, 1985 | SESE | | [K852583](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFM/K852583.md) | DATA CHEM IRON PROCEDURE | Data Medical Associates, Inc. | Jul 12, 1985 | SESE | | [K842505](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFM/K842505.md) | TDX REA IRON DIAGNOSTIC KIT | Abbott Laboratories | Aug 7, 1984 | SESE | | [K842156](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFM/K842156.md) | SERUM IRON & SERUM IRON BINDING CAPACITY | Diagnostic Chemicals, Ltd. (Usa) | Aug 7, 1984 | SESE | | [K842155](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFM/K842155.md) | SERUM IRON & SERUM IRON BINDING CAPACI | Diagnostic Chemicals, Ltd. (Usa) | Aug 7, 1984 | SESE | | [K840485](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFM/K840485.md) | TOTAL IRON UIBC/TIBC ASSAY | Somas Medical Industries, Inc. | Mar 12, 1984 | SESE | | [K834396](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFM/K834396.md) | DIRECT IRON REAGENT SET | Seragen Diagnostics, Inc. | Feb 21, 1984 | SESE | | [K830564](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFM/K830564.md) | FEB TEST | Wako Chemicals USA, Inc. | Mar 29, 1983 | SESE | | [K820629](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFM/K820629.md) | CORNING 902 SODIUM POTASSIUM ANALYZER | Corning Medical & Scientific | Mar 25, 1982 | SESE | | [K810085](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFM/K810085.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFM](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFM) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com