CHL — Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph Class II
FDA Device Classification
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 |
|---|
| 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 |
| K151856 | sendx medical | ABL80 FLEX CO-OX with AQURE connectivity | August 6, 2015 |