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 862.1330](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1330) → JGE — Turbidimetric Method, Globulin

# JGE · Turbidimetric Method, Globulin

_Clinical Chemistry · 21 CFR 862.1330 · Class 1_

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

## Overview

- **Product Code:** JGE
- **Device Name:** Turbidimetric Method, Globulin
- **Regulation:** [21 CFR 862.1330](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1330)
- **Device Class:** 1
- **Review Panel:** [Clinical Chemistry](/submissions/CH)

## Identification

A globulin test system is a device intended to measure globulins (proteins) in plasma and serum. Measurements of globulin are used in the diagnosis and treatment of patients with numerous illnesses including severe liver and renal disease, multiple myeloma, and other disorders of blood globulins.

## 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 § 862.9.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K980055](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JGE/K980055.md) | CARESIDE GLOBULIN | Exigent Diagnostics, Inc. | Jan 28, 1998 | SESE |

## Top Applicants

- Exigent Diagnostics, Inc. — 1 clearance

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

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