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 862.1170](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1170) → CHG — Acid, Phosphoric-Tungstic (Spectrophotometric), Chloride

# CHG · Acid, Phosphoric-Tungstic (Spectrophotometric), Chloride

_Clinical Chemistry · 21 CFR 862.1170 · Class 2_

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

## Overview

- **Product Code:** CHG
- **Device Name:** Acid, Phosphoric-Tungstic (Spectrophotometric), Chloride
- **Regulation:** [21 CFR 862.1170](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1170)
- **Device Class:** 2
- **Review Panel:** [Clinical Chemistry](/submissions/CH)
- **3rd-party reviewable:** yes

## Identification

A chloride test system is a device intended to measure the level of chloride in plasma, serum, sweat, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

## Classification Rationale

Class II.

## Recent Cleared Devices (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K941807](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHG/K941807.md) | INTERSECT SYSTEMS' NON-MERCURIC CHLORIDE REAGENT | Intersect Systems, Inc. | Sep 14, 1994 | SESE |
| [K934588](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHG/K934588.md) | CHLORIDE (MF) ASSAY | Diagnostic Chemicals , Ltd. | Feb 18, 1994 | SESE |
| [K903103](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHG/K903103.md) | SYNERMED CHLORIDE REAGENT KIT | Synermed, Inc. | Aug 9, 1990 | SESE |

## Top Applicants

- Diagnostic Chemicals , Ltd. — 1 clearance
- Intersect Systems, Inc. — 1 clearance
- Synermed, Inc. — 1 clearance

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

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