NFX · Test, Cholesterol, Total, Over The Counter
Clinical Chemistry · 21 CFR 862.1175 · Class 1
Overview
| Product Code | NFX |
|---|---|
| Device Name | Test, Cholesterol, Total, Over The Counter |
| Regulation | 21 CFR 862.1175 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
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 (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K033899 | LIFESTREAM PLUS CHOLESTEROL MONITOR, MODIFICATION TO RESOLUTION CHOLESTEROL MONITOR | Lifestream Technologies, Inc. | May 20, 2004 | SESE |
Top Applicants
- Lifestream Technologies, Inc. — 1 clearance
