JKS · Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide
Clinical Toxicology · 21 CFR 862.3220 · Class 1
Overview
| Product Code | JKS |
|---|---|
| Device Name | Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide |
| 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 (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K951485 | AVOXIMETER 4000 | A-Vox Systems, Inc. | Nov 6, 1995 | SESE |
| K863825 | CO-OXIMETER SOLUTIONS | D.R.G. Scientific Industries | Nov 24, 1986 | SESE |
| K862253 | IL 482 CO-OXIMETER | Instrumentation Laboratory CO | Jul 29, 1986 | SESE |
| K853990 | OSM3 HEMOXIMETER | Radiometer America, Inc. | Dec 30, 1985 | SESE |
| K833693 | TEE ADAPTER 9890-FLUSH WINDING 282 | Shaban Mfg. Co. | Dec 30, 1983 | SESE |
| K833211 | BILE SALTS MIXTURE | Acumedia Manufacturers, Inc. | Oct 27, 1983 | SESE |
| K832066 | CONTROL 282 | Bio-Nustics, Inc. | Sep 29, 1983 | SESE |
| K780652 | HEMOGLOBIN CHECK SOLUTIONS, S2100 OSM-2 | The London Co. | Jul 27, 1978 | SESE |
Top Applicants
- A-Vox Systems, Inc. — 1 clearance
- Acumedia Manufacturers, Inc. — 1 clearance
- Bio-Nustics, Inc. — 1 clearance
- D.R.G. Scientific Industries — 1 clearance
- Instrumentation Laboratory CO — 1 clearance
