JHL · Microdensitometry Method, Lipoproteins
Clinical Chemistry · 21 CFR 862.1475 · Class 1
Overview
| Product Code | JHL |
|---|---|
| Device Name | Microdensitometry Method, Lipoproteins |
| Regulation | 21 CFR 862.1475 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
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.
Cleared Devices (1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K770948 | LIPOPROTEIN PROFILING SYSTEM | Beckman Instruments, Inc. | Jul 15, 1977 | SESE |
Top Applicants
- Beckman Instruments, Inc. — 1 clearance
