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) → JQG — Radiometric, Fe59, Iron Binding Capacity

# JQG · Radiometric, Fe59, 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/JQG

## Overview

- **Product Code:** JQG
- **Device Name:** Radiometric, Fe59, 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 (5 of 5)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K811954](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JQG/K811954.md) | COMBO-FER IRON DIAGNOSTIC | Immuno Assay Corp. | Jul 27, 1981 | SESE |
| [K800710](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JQG/K800710.md) | FERRITIRON KIT CAT. #RP-1100 | Ria Products, Inc. | May 14, 1980 | SESE |
| [K800868](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JQG/K800868.md) | FERRO-QUANT TM FE 59 TEST KIT | Mallinckrodt Critical Care | Apr 29, 1980 | SESE |
| [K790133](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JQG/K790133.md) | SPINSEP-FE59 | Nuclear Diagnostics, Inc. | Mar 2, 1979 | SESE |
| [K780412](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JQG/K780412.md) | TOTAL IRON BINDING CAPACITY | Diagnostic Corp. of America | May 26, 1978 | SESE |

## Top Applicants

- Diagnostic Corp. of America — 1 clearance
- Immuno Assay Corp. — 1 clearance
- Mallinckrodt Critical Care — 1 clearance
- Nuclear Diagnostics, Inc. — 1 clearance
- Ria Products, Inc. — 1 clearance

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

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