CHL
- Product code
- CHL
- Device name
- Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
- Device class
- Class 2
- 21 CFR
- 21 CFR 862.1120
- Medical specialty
- Clinical Chemistry
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 188
510(k) clearances, last 3 years (6)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K252207 | 2026-04-10 | Radiometer Medicals Aps | ABL90 FLEX PLUS System, safeCLINITUBES | |
| K244014 | 2025-05-02 | Abbott Point of Care, Inc. | i-STAT CG4+ cartridge with the i-STAT 1 System | |
| K240998 | 2024-12-13 | Radiometer Medicals Aps | ABL90 FLEX PLUS System | FDA |
| K230285 | 2023-10-27 | Abbott Point of Care, Inc. | i-STAT CG8+ cartridge with the i-STAT 1 System | |
| K221900 | 2023-09-29 | Nova Biomedical Corporation | Stat Profile Prime Plus Analyzer System | |
| K223857 | 2023-09-15 | Abbott Point of Care, Inc. | i-STAT G3+ cartridge with the i-STAT 1 System |
Official FDA classification page: CHL
Classification and pathway per current FDA publications. Data from openFDA (CC0).