JHN · Turbidimetric Method, Lipoproteins
Clinical Chemistry · 21 CFR 862.1475 · Class 1
Overview
| Product Code | JHN |
|---|---|
| Device Name | Turbidimetric 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.
Recent Cleared Devices (7 of 7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K950383 | APOLIPOPROTEIN A-I IMMUNOTURBIDIMETRIC KIT | Randox Laboratories, Ltd. | Sep 15, 1995 | SESE |
| K950382 | APOLIPOPROTEIN B IMMUNOTURBIDIEMETRIC KIT | Randox Laboratories, Ltd. | Sep 15, 1995 | SESE |
| K952615 | WAKO AUTOKIT APO A1 | Wako Chemicals USA, Inc. | Sep 8, 1995 | SESE |
| K952425 | OLYMPUS APOLIPOPROTEIN A1 IMMUNOTURBIDIMETRIC REAGENT | Olympus America, Inc. | Jul 5, 1995 | SESE |
| K952466 | OLYMPUS APOLIPOPROTEIN B IMMUNOTURBIDIMETRIC REAGENT | Olympus America, Inc. | Jun 5, 1995 | SESE |
| K932606 | APOLIPOPROTIEN A-1 (APO A-1) | Sigma Diagnostics, Inc. | Jun 2, 1994 | SESE |
| K932603 | APOLIPOPROTIEN B (APO B) | Sigma Diagnostics, Inc. | Jun 2, 1994 | SESE |
Top Applicants
- Sigma Diagnostics, Inc. — 2 clearances
- Randox Laboratories, Ltd. — 2 clearances
- Olympus America, Inc. — 2 clearances
- Wako Chemicals USA, Inc. — 1 clearance
