MRS · Test System, Nicotine, Cotinine, Metabolites
Clinical Toxicology · 21 CFR 862.3220 · Class 1
Overview
| Product Code | MRS |
|---|---|
| Device Name | Test System, Nicotine, Cotinine, Metabolites |
| Regulation | 21 CFR 862.3220 |
| Device Class | Class 1 |
| Review Panel | Clinical Toxicology |
Identification
A carbon monoxide test system is a device intended to measure carbon monoxide or carboxyhemoglobin (carbon monoxide bound to the hemoglobin in the blood) in blood. Measurements obtained by this device are used in the diagnosis and treatment of or confirmation of carbon monoxide poisoning.
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 the limitations in § 862.9.
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K030649 | DRI COTININE EIA ASSAY | Microgenics Corp. | May 22, 2003 | SESE |
| K021688 | NICALERT | Nymox Pharmaceutical Corporation | Oct 18, 2002 | SESE |
| K963733 | NICCHECK I | Dynagen, Inc. | Dec 13, 1996 | SESE |
Top Applicants
- Dynagen, Inc. — 1 clearance
- Microgenics Corp. — 1 clearance
- Nymox Pharmaceutical Corporation — 1 clearance
