CHD · Acid, Ferric Ion-Sulfuric, Cholesterol
Clinical Chemistry · 21 CFR 862.1175 · Class 1
Overview
| Product Code | CHD |
|---|---|
| Device Name | Acid, Ferric Ion-Sulfuric, Cholesterol |
| Regulation | 21 CFR 862.1175 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
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 | CHOLESTEROL REAGENT SET | Medical Specialties, Inc. | May 1, 1984 | SESE |
| K830616 | ACTIVATED URIC ACID | American Monitor Corp. | Apr 5, 1983 | SESE |
| K821195 | 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
