GHS · Assay, Carboxyhemoglobin
Hematology · 21 CFR 864.7425 · Class 2
Overview
| Product Code | GHS |
|---|---|
| Device Name | Assay, Carboxyhemoglobin |
| Regulation | 21 CFR 864.7425 |
| Device Class | Class 2 |
| Review Panel | Hematology |
| 3rd-Party Reviewable | Yes |
Identification
A carboxyhemoglobin assay is a device used to determine the carboxyhemoglobin (the compound formed when hemoglobin is exposed to carbon monoxide) content of human blood as an aid in the diagnosis of carbon monoxide poisoning. This measurement may be made using methods such as spectroscopy, colorimetry, spectrophotometry, and gasometry.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K974805 | CO-STAT(TM) END TIDAL BREATH ANALYZER | Natus Medical, Inc. | Mar 11, 1998 | SESE |
| K910827 | ABL520 BLOOD GAS SYSTEM | Radiometer America, Inc. | Jul 9, 1991 | SESE |
| K790943 | TRISEDTA-BORATE ELECTROPHORESIS FILM AGA | Corning Medical & Scientific | Jun 22, 1979 | SESE |
| K771263 | RADIOMHTER OSM-2 HEMOXIMETER | The London Co. | Aug 3, 1977 | SESE |
| K770209 | ECOLYZER CARBOXIMETER | Iadec, Inc. | Mar 7, 1977 | SESE |
Top Applicants
- Corning Medical & Scientific — 1 clearance
- Iadec, Inc. — 1 clearance
- Natus Medical, Inc. — 1 clearance
- Radiometer America, Inc. — 1 clearance
- The London Co. — 1 clearance
