CHL — Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph Class II
FDA product code CHL covers "Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph", a Class II medical device regulated under 21 CFR 862.1120. Submissions are reviewed by the Clinical Chemistry panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- CHL
- Device Class
- Class II
- Regulation Number
- 862.1120
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252207 | Radiometer Medicals Aps | ABL90 FLEX PLUS System, safeCLINITUBES | Apr 10, 2026 |
| K244014 | Abbott Point Of Care | i-STAT CG4+ cartridge with the i-STAT 1 System | May 2, 2025 |
| K240998 | Radiometer Medicals Aps | ABL90 FLEX PLUS System | Dec 13, 2024 |
| K230285 | Abbott Point Of Care | i-STAT CG8+ cartridge with the i-STAT 1 System | Oct 27, 2023 |
| K221900 | Nova Biomedical Corporation | Stat Profile Prime Plus Analyzer System | Sep 29, 2023 |
| K223857 | Abbott Point Of Care | i-STAT G3+ cartridge with the i-STAT 1 System | Sep 15, 2023 |
| K223608 | Instrumentation Laboratory | GEM Premier 7000 with IQM3 | Aug 10, 2023 |
| K211559 | Medica Corporation | EasyStat 300 | Jan 27, 2023 |
| K203790 | Instrumentation Laboratory | GEM Premier 5000 | Aug 20, 2021 |
| K200986 | Opti Medical Systems | OPTI® B-Lac Cassette | Aug 2, 2021 |
| K200107 | Epocal | epoc Blood Analysis System | Jun 5, 2020 |
| K200492 | Abbott Point Of Care | i-STAT CG4+ Cartridge with the i-STAT 1 System | Apr 9, 2020 |
| K192240 | Siemens Healthcare Diagnostics | RAPIDPoint 500e Blood Gas System | Mar 27, 2020 |
| K193246 | Nova Biomedical Corporation | Stat Profile Prime Plus Analyzer System | Jan 24, 2020 |
| K173797 | Nova Biomedical Corporation | Stat Profile Prime Plus Analyzer System | Jul 17, 2018 |
| K173403 | Instrumentation Laboratory | GEM Premier 5000 | Dec 29, 2017 |
| K160412 | Instrumentation Laboratory | GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2) | Dec 14, 2016 |
| K160153 | Radiometer Medical Aps | ABL90 FLEX PLUS | Nov 4, 2016 |
| K151978 | Edan Instruments | EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid Pack, | Jul 15, 2016 |
| K151982 | Nova Biomedical Corporation | Stat Profile Prime ABG Analyzer System | Sep 10, 2015 |