Product code GHS
- Device name
- Assay, Carboxyhemoglobin
- Medical specialty
- Hematology
- Device class
- 2
- Regulation number
- 864.7425
- Review panel
- HE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K974805 | CO-STAT(TM) END TIDAL BREATH ANALYZER | Natus Medical, Inc. | 1998-03-11 |
| K910827 | ABL520 BLOOD GAS SYSTEM | Radiometer America, Inc. | 1991-07-09 |
| K790943 | TRISEDTA-BORATE ELECTROPHORESIS FILM AGA | Corning Medical & Scientific | 1979-06-22 |
| K771263 | RADIOMHTER OSM-2 HEMOXIMETER | The London Co. | 1977-08-03 |
| K770209 | ECOLYZER CARBOXIMETER | Iadec, Inc. | 1977-03-07 |
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| 05700693930978 | ABL90 FLEX | Radiometer Medical ApS | 2026-07-09 |
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| 05700699461131 | SC90 | Radiometer Medical ApS | 2026-07-09 |
| 05700699461100 | SC90 | Radiometer Medical ApS | 2026-07-09 |
| 05700699461094 | SC90 | Radiometer Medical ApS | 2026-07-09 |
| 05700699461087 | SC90 | Radiometer Medical ApS | 2026-07-09 |
| 05700699461056 | SC90 | Radiometer Medical ApS | 2026-07-09 |
| 05700699447579 | SP90 | Radiometer Medical ApS | 2026-07-09 |
| 05700699446572 | SP90 | Radiometer Medical ApS | 2026-07-09 |
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