NAQ · Lipoprotein, High Density, Hdl, Over The Counter
Clinical Chemistry · 21 CFR 862.1175 · Class 1
Overview
| Product Code | NAQ |
|---|---|
| Device Name | Lipoprotein, High Density, Hdl, 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.
Cleared Devices (2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K060617 | PTS PANELS HDL CHOLESTEROL TEST STRIPS | Polymer Technology Systems, Inc. | Apr 5, 2006 | SESE |
| K993377 | MTM BIOSCANNER HDL TEST STRIPS, OVER THE COUNTER (OTC) | Polymer Technology Systems, Inc. | Jan 13, 2000 | SESE |
Top Applicants
- Polymer Technology Systems, Inc. — 2 clearances
