GHS — Assay, Carboxyhemoglobin Class II
FDA product code GHS covers "Assay, Carboxyhemoglobin", a Class II medical device regulated under 21 CFR 864.7425. Submissions are reviewed by the Hematology panel. At least 5 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GHS
- Device Class
- Class II
- Regulation Number
- 864.7425
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K974805 | natus medical | CO-STAT(TM) END TIDAL BREATH ANALYZER | March 11, 1998 |
| K910827 | radiometer america | ABL520 BLOOD GAS SYSTEM | July 9, 1991 |
| K790943 | corning medical and scientific | TRISEDTA-BORATE ELECTROPHORESIS FILM AGA | June 22, 1979 |
| K771263 | london | RADIOMHTER OSM-2 HEMOXIMETER | August 3, 1977 |
| K770209 | iadec | ECOLYZER CARBOXIMETER | March 7, 1977 |