CGO · Lieberman-Burchard/Abell-Kendall, Colorimetric, Cholesterol
Clinical Chemistry · 21 CFR 862.1175 · Class 1
Overview
| Product Code | CGO |
|---|---|
| Device Name | Lieberman-Burchard/Abell-Kendall, Colorimetric, 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.
Cleared Devices (11)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K850938 | CHOLESTEROL | Dilab, Inc. | Jun 25, 1985 | SESE |
| K811747 | KING DIAGNOSTICS CHOLESTEROL TEST | King Diagnostics, Inc. | Jul 10, 1981 | SESE |
| K810090 | CHOLESTEROL REAGENT | Anco Medical Reagents & Assoc. | Jan 26, 1981 | SESE |
| K800682 | REAGENTS FOR DETERM. CHOLESTEROL/SERUM | Diagnostic Solutions, Inc. | May 28, 1980 | SESE |
| K781611 | CHOLESTEROL DET. IN SERUM | Fisher Scientific Co., LLC | Oct 24, 1978 | SESE |
| K780545 | SR-PLUS DIRECT CHOLESTEROL TEST | Stanbio Laboratory | May 26, 1978 | SESE |
| K772043 | ALPHA/CHOL | Standard Scientific, Inc. | Nov 28, 1977 | SESE |
| K771833 | CHOLESTEROL | Gamma Enterprises, Inc. | Oct 18, 1977 | SESE |
| K771313 | CHOLESTEROL REAGENT | Mallinckrodt Critical Care | Aug 3, 1977 | SESE |
| K771093 | UNIPAK CHOLESTEROL | Harleco | Jul 21, 1977 | SESE |
| K770457 | CHOLESTEROL PROCEDURE, TEKPOINT TOTAL | Icn Pharmaceuticals, Inc. | May 3, 1977 | SESE |
Top Applicants
- Standard Scientific, Inc. — 1 clearance
- Stanbio Laboratory — 1 clearance
- Mallinckrodt Critical Care — 1 clearance
- King Diagnostics, Inc. — 1 clearance
- Icn Pharmaceuticals, Inc. — 1 clearance
