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 862.1175](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1175) → CHD — Acid, Ferric Ion-Sulfuric, Cholesterol

# CHD · Acid, Ferric Ion-Sulfuric, Cholesterol

_Clinical Chemistry · 21 CFR 862.1175 · Class 1_

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

## Overview

- **Product Code:** CHD
- **Device Name:** Acid, Ferric Ion-Sulfuric, Cholesterol
- **Regulation:** [21 CFR 862.1175](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1175)
- **Device Class:** 1
- **Review Panel:** [Clinical Chemistry](/submissions/CH)

## Identification

A cholesterol (total) test system is a device intended to measure cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.

## 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 (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K841052](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHD/K841052.md) | CHOLESTEROL REAGENT SET | Medical Specialties, Inc. | May 1, 1984 | SESE |
| [K830616](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHD/K830616.md) | ACTIVATED URIC ACID | American Monitor Corp. | Apr 5, 1983 | SESE |
| [K821195](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHD/K821195.md) | CHOLESTEROL REAGENT SET | Omega Medical Electronics | Jul 13, 1982 | SESE |

## Top Applicants

- American Monitor Corp. — 1 clearance
- Medical Specialties, Inc. — 1 clearance
- Omega Medical Electronics — 1 clearance

---

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

**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