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 862.1415](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1415) → JQF — Bathophenanthroline, Iron Binding Capacity

# JQF · Bathophenanthroline, Iron Binding Capacity

_Clinical Chemistry · 21 CFR 862.1415 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JQF

## Overview

- **Product Code:** JQF
- **Device Name:** Bathophenanthroline, Iron Binding Capacity
- **Regulation:** [21 CFR 862.1415](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1415)
- **Device Class:** 1
- **Review Panel:** [Clinical Chemistry](/submissions/CH)

## Identification

An iron-binding capacity test system is a device intended to measure iron-binding capacity in serum. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia.

## 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 (8 of 8)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K051111](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JQF/K051111.md) | SENTINEL UIBC LIQUID | Sentinel Ch. Srl | Nov 17, 2005 | SESE |
| [K984122](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JQF/K984122.md) | WAKO L-TYPE UIBC, WAKO UIBC CALIBRATOR | Wako Chemicals USA, Inc. | Jan 20, 1999 | SESE |
| [K875176](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JQF/K875176.md) | WAKO(TM) UIBC | Wako Chemicals USA, Inc. | Feb 2, 1988 | SESE |
| [K863066](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JQF/K863066.md) | TRANSFERMETER | J. D. Assoc. | Dec 4, 1986 | SESE |
| [K830032](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JQF/K830032.md) | TOTAL IRON BINDING CAPACITY TEST | Sclavo, Inc. | Jan 28, 1983 | SESE |
| [K811942](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JQF/K811942.md) | J & S IRON SATURATING REAGENT | Thyroid Diagnostics, Inc. | Sep 8, 1981 | SESE |
| [K810086](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JQF/K810086.md) | IRON & TICB | Bio-Analytics Laboratories, Inc. | Jan 28, 1981 | SESE |
| [K792409](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JQF/K792409.md) | ELVI TOTAL IRON BINDING CAPACITY | Volu Sol Medical Industries | Dec 6, 1979 | SESE |

## Top Applicants

- Wako Chemicals USA, Inc. — 2 clearances
- Bio-Analytics Laboratories, Inc. — 1 clearance
- J. D. Assoc. — 1 clearance
- Sclavo, Inc. — 1 clearance
- Sentinel Ch. Srl — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JQF](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JQF)

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