GHS
5 FDA 510(k) clearances · Product code
35 daysmedian time to decision
132 days90th percentile
5clearances measured
FDA profile
- Official device name
- Assay, Carboxyhemoglobin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7425
- Medical specialty
- Hematology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| CO-STAT(TM) END TIDAL BREATH ANALYZER (K974805) | Natus Medical, Inc. | 1998-03-11 |
| ABL520 BLOOD GAS SYSTEM (K910827) | Radiometer America, Inc. | 1991-07-09 |
| TRISEDTA-BORATE ELECTROPHORESIS FILM AGA (K790943) | Corning Medical & Scientific | 1979-06-22 |
| RADIOMHTER OSM-2 HEMOXIMETER (K771263) | The London Co. | 1977-08-03 |
| ECOLYZER CARBOXIMETER (K770209) | Iadec, Inc. | 1977-03-07 |
Track GHS automatically
Every clearance here is in the API, with alerts when new ones post.