MKU · Enzyme Immunoassay, Nicotine And Nicotine Metabolites
Clinical Toxicology · 21 CFR 862.3220 · Class 1
Overview
| Product Code | MKU |
|---|---|
| Device Name | Enzyme Immunoassay, Nicotine And Nicotine 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 (7 of 7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K192517 | Psychemedics Microplate EIA for Cotinine in Hair | Psychemedics Corporation | Apr 22, 2020 | SESE |
| K192299 | LZI Cotinine II Enzyme Immunoassay | Lin-Zhi International, Inc. | Nov 21, 2019 | SESE |
| K062565 | STATUS DS NICOTINE, ACCUSIGN NICOTINE, BIOSIGN NICOTINE | Princeton BioMeditech Corp. | Feb 20, 2007 | SESE |
| K021944 | COZART EIA COTININE URINE KIT | Cozart Bioscience , Ltd. | May 14, 2003 | SESE |
| K974534 | MICRO-PLATE COTININE EIA | OraSure Technologies, Inc. | May 18, 1998 | SESE |
| K974234 | MICRO-PLATE COTININE EIA | OraSure Technologies, Inc. | May 14, 1998 | SESE |
| K972481 | AUTO-LYTE COTININE EIA | OraSure Technologies, Inc. | Oct 21, 1997 | SESE |
Top Applicants
- OraSure Technologies, Inc. — 3 clearances
- Cozart Bioscience , Ltd. — 1 clearance
- Lin-Zhi International, Inc. — 1 clearance
- Princeton BioMeditech Corp. — 1 clearance
- Psychemedics Corporation — 1 clearance
