LBT · Electrophoresis, Cholesterol Via Esterase-Oxidase, Hdl
Clinical Chemistry · 21 CFR 862.1475 · Class 1
Overview
| Product Code | LBT |
|---|---|
| Device Name | Electrophoresis, Cholesterol Via Esterase-Oxidase, Hdl |
| 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 (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K000568 | HDL CHOLESTEROL PLUS | Roche Diagnostics Corp. | Aug 4, 2000 | SESE |
| K990250 | HYDRAGEL LDL/HDL CHOL DIRECT KIT-P.N. 4005, HYDRAGEL 7 LDL/HDL CHOL DIRECT KIT-P.N. 4103, HYDRAGEL LDL/HDL CHOL DIRECT 0 | Morax | Jun 18, 1999 | SESE |
| K972015 | HYDRAGEL 7,15,30, CHOL-HDL KIT | Morax | Oct 27, 1997 | SESE |
| K904035 | REP ULTRA HDL,VLDL/LDL CHOLESTEROL SYSTEM | Helena Laboratories | Nov 9, 1990 | SESE |
| K894366 | REP HDL-8 KIT, NO. 3188, REP HDL-16 KIT, NO. 3187 | Helena Laboratories | Aug 31, 1989 | SESE |
| K882368 | REP HDL ELECTROPHORESIS METHOD | Helena Laboratories | Aug 8, 1988 | SESE |
| K873547 | TITAN GEL HDL CHOLESTEROL KIT | Helena Laboratories | Oct 2, 1987 | SESE |
| K790791 | ELECTROPHORESIS REAGENT SET, HDL | Gelman Sciences, Inc. | Jun 15, 1979 | SESE |
Top Applicants
- Helena Laboratories — 4 clearances
- Morax — 2 clearances
- Gelman Sciences, Inc. — 1 clearance
- Roche Diagnostics Corp. — 1 clearance
