Assay, Carboxyhemoglobin
FDA product code GHS · Class II (moderate risk) · 21 CFR 864.7425 · Hematology
5510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K974805 | Co-Stat(Tm) End Tidal Breath AnalyzerGHS · Traditional | Natus Medical, Inc. | 03/11/1998SE |
| K910827 | ABL520 Blood Gas SystemGHS · Traditional | Radiometer America, Inc. | 07/09/1991SE |
| K790943 | Trisedta-Borate Electrophoresis Film AgaGHS · Traditional | Corning Medical & Scientific | 06/22/1979SE |
| K771263 | Radiomhter OSM-2 HemoximeterGHS · Traditional | The London Co. | 08/03/1977SE |
| K770209 | Ecolyzer CarboximeterGHS · Traditional | Iadec, Inc. | 03/07/1977SE |