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 | April 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 | December 13, 2024 |
| K230285 | abbott point of care | i-STAT CG8+ cartridge with the i-STAT 1 System | October 27, 2023 |
| K221900 | nova biomedical corporation | Stat Profile Prime Plus Analyzer System | September 29, 2023 |
| K223857 | abbott point of care | i-STAT G3+ cartridge with the i-STAT 1 System | September 15, 2023 |
| K223608 | instrumentation laboratory | GEM Premier 7000 with IQM3 | August 10, 2023 |
| K211559 | medica corporation | EasyStat 300 | January 27, 2023 |
| K203790 | instrumentation laboratory | GEM Premier 5000 | August 20, 2021 |
| K200986 | opti medical systems | OPTI® B-Lac Cassette | August 2, 2021 |
| K200107 | epocal | epoc Blood Analysis System | June 5, 2020 |
| K200492 | abbott point of care | i-STAT CG4+ Cartridge with the i-STAT 1 System | April 9, 2020 |
| K192240 | siemens healthcare diagnostics | RAPIDPoint 500e Blood Gas System | March 27, 2020 |
| K193246 | nova biomedical corporation | Stat Profile Prime Plus Analyzer System | January 24, 2020 |
| K173797 | nova biomedical corporation | Stat Profile Prime Plus Analyzer System | July 17, 2018 |
| K173403 | instrumentation laboratory | GEM Premier 5000 | December 29, 2017 |
| K160412 | instrumentation laboratory | GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2) | December 14, 2016 |
| K160153 | radiometer medical aps | ABL90 FLEX PLUS | November 4, 2016 |
| K151978 | edan instruments | EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid Pack, | July 15, 2016 |
| K151982 | nova biomedical corporation | Stat Profile Prime ABG Analyzer System | September 10, 2015 |